An analysis of valve re-replacement after aortic valve replacement with biologic devices

Biologic valve re-replacement was examined in a series of 1343 patients who underwent aortic valve replacement at The Prince Charles Hospital, Brisbane, with a cryopreserved or 4 degrees C stored allograft valve or a xenograft valve, A parametric model approach was used to simultaneously model the competing risks of death without re-replacement and re-replacement before death, One hundred eleven patients underwent a first re-replacement for a variety of reasons (69 patients with xenograft valves, 28 patients with 4 degrees C stored allograft valves, and 14 patients with cryopreserved allograft valves), By multivariable analysis younger age at operation was associated with xenograft, 4 degrees C stored allograft, and cryopreserved allograft valve re-replacement, However, this effect was examined in the context of longer survival of younger patients, which increases their exposure to the risk of re-replacement as compared with that in older patients whose decreased survival reduced their probability of requiring valve re-replacement, In patients older than 60 years at the time of aortic valve replacement, the probability of re-replacement (for any reason) before death was similar for xenografts and cryopreserved allograft valves but higher for 4 degrees C stored valves, However, in patients younger than 60 years, the probability of re-replacement at any time during the remainder of the life of the patient was lower with the cryopreserved allograft valve compared with the xenograft valve and 4 degrees C stored allografts.

Surgical repair of a pseudoaneurysm of the ascending aorta after aortic valve replacement

We report the case of a patient with a pseudoaneurysm of the ascending aortic clinically diagnosed 5 months after surgical replacement of the aortic valve. Diagnosis was confirmed with the aid of two-dimensional echocardiography and helicoidal angiotomography. The corrective surgery, which consisted of a reinforced suture of the communication with the ascending aorta after opening and aspiration of the cavity of the pseudoaneurysm, was successfully performed through a complete sternotomy using extracorporeal circulation, femorofemoral cannulation, and moderate hypothermia, with no aortic clamping.

Transcatheter aortic valve replacement for degenerative bioprosthetic surgical valves: Results from the global valve-in-valve registry.

BACKGROUND Transcatheter aortic valve-in-valve implantation is an emerging therapeutic alternative for patients with a failed surgical bioprosthesis and may obviate the need for reoperation. We evaluated the clinical results of this technique using a large, worldwide registry. METHODS AND RESULTS The Global Valve-in-Valve Registry included 202 patients with degenerated bioprosthetic valves (aged 77.7±10.4 years; 52.5% men) from 38 cardiac centers. Bioprosthesis mode of failure was stenosis (n=85; 42%), regurgitation (n=68; 34%), or combined stenosis and regurgitation (n=49; 24%). Implanted devices included CoreValve (n=124) and Edwards SAPIEN (n=78). Procedural success was achieved in 93.1% of cases. Adverse procedural outcomes included initial device malposition in 15.3% of cases and ostial coronary obstruction in 3.5%. After the procedure, valve maximum/mean gradients were 28.4±14.1/15.9±8.6 mm Hg, and 95% of patients had ≤+1 degree of aortic regurgitation. At 30-day follow-up, all-cause mortality was 8.4%, and 84.1% of patients were at New York Heart Association functional class I/II. One-year follow-up was obtained in 87 patients, with 85.8% survival of treated patients. CONCLUSIONS The valve-in-valve procedure is clinically effective in the vast majority of patients with degenerated bioprosthetic valves. Safety and efficacy concerns include device malposition, ostial coronary obstruction, and high gradients after the procedure.

Endoscopic off-pump aortic valve replacement: does the pericardial cuff improve the sutureless closure of left ventricular access?

OBJECTIVE: Off-pump trans left ventricular approach provides more precise deployment of stented aortic valve of any size with respect to the endovascular replacement. One of the key steps of this procedure is the ventricle repair after catheter withdrawing. We designed an animal study to compare the consistency of a sutureless repair of the left ventricle access using nitinol occluder with and without pericardial cuff on the ventricular side. METHODS: Material description: The Amplatz-nitinol occluder consists of two square heads squeezing ventricle wall in between them, sealing the defect. To improve its sealing property, a pericardial patch was sutured to the ventricular head of the occluder. Animal study setup: In adult pigs, a 30F sheath was inserted into the epigastric area through the cardiac apex, up to the left ventricle, simulating the approach for off-pump aortic valve replacement. The sheath was then removed and the ventricle closed with standard occluder in half of the animals, and cuffed occluder in the other half. Animals were followed-up for 3h, collecting haemodynamics data and pericardial bleeding. RESULTS: Device was successfully deployed in 12 animals in less than 1min. In the group where the standard occluder was used, bleeding during the deployment was 80+/-20ml and after the deployment was 800+/-20ml over 3h. In the group where the cuffed occluder was used, bleeding during the deployment was 85+/-20ml and after the deployment was 100+/-5ml over 3h. In the cuffed group, bleeding was significantly lower than the standard group, p-value being <0.001. CONCLUSIONS: The occluder is easy to use and the pericardial cuff dramatically increases its efficacy as demonstrated by a significant reduction of blood loss. The cuffed occluder opens the way for endoscopic, off-pump, transventricular aortic valve replacement.

Transapical aortic valve replacement through a chronic apical aneurysm.

Transapical aortic valve replacement through an apical aneurysm is traditionally contraindicated because of the risk of severe systemic embolization when thrombi are present. However, a chronic fibrotic aneurysm without apical thrombi carries a low risk of distal embolization and can be safely employed for a transapical transcatheter aortic valve replacement in case of absence of an alternative access site (severe vascular disease, small vascular sizes and diseased calcified aorta). We illustrate our experience with a 73-year-old patient suffering from symptomatic aortic valve stenosis, coronary artery disease with occluded left anterior descending artery, left ventricular apical aneurysm and severe peripheral vascular disease, who successfully underwent a transapical 26 mm Sapien? XT stent-valve implantation through the fibrotic thin akinetic apical wall.

A new training set-up for trans-apical aortic valve replacement.

Trans-apical aortic valve replacement (AVR) is a new and rapidly growing therapy. However, there are only few training opportunities. The objective of our work is to build an appropriate artificial model of the heart that can replace the use of animals for surgical training in trans-apical AVR procedures. To reduce the necessity for fluoroscopy, we pursued the goal of building a translucent model of the heart that has nature-like dimensions. A simplified 3D model of a human heart with its aortic root was created in silico using the SolidWorks Computer-Aided Design (CAD) program. This heart model was printed using a rapid prototyping system developed by the Fab@Home project and dip-coated two times with dispersion silicone. The translucency of the heart model allows the perception of the deployment area of the valved-stent without using heavy imaging support. The final model was then placed in a human manikin for surgical training on trans-apical AVR procedure. Trans-apical AVR with all the necessary steps (puncture, wiring, catheterization, ballooning etc.) can be realized repeatedly in this setting.

Towards no-scar cardiac surgery - minimally invasive access through umbilicus for aortic valve replacement.

There is an ever-growing trend towards less-invasive procedures in all fields of medicine. We designed an animal study to prove the concept that trans-apical aortic valve replacement from an incision within the umbilicus through a single channel for instruments is feasible, which would be a major leap towards no-scar cardiac surgery. In three adult pigs, after creating a single 3-cm incision at a place where the human umbilicus would be, we introduced a 30F sheath through a tunnel created by an endoscopic vein-harvesting device up to the cardiac apex, through it and up to the left ventricle simulating the approach for trans-apical aortic valve replacement. We used a standard Amplatz nitinol occluder to seal the defect in ventricle wall later. The animals were followed up for 1h. Blood loss was minimal, and no tamponade occurred in any of the animals. In addition, we performed a test with water column static pressure to evaluate the impact of preclotting on the sealing properties of the occluders: 1 min flow-through was 2860+/-176 ml for the standard occluders and 348+/-56 ml for preclotted occluders (p<0.001).

Feasibility of transapical aortic valve replacement through a left ventricular apical diverticulum.

ABSTRACT: Transapical aortic valve replacement is an established technique performed in high-risk patients with symptomatic aortic valve stenosis and vascular disease contraindicating trans-vascular and trans-aortic procedures. The presence of a left ventricular apical diverticulum is a rare event and the treatment depends on dimensions and estimated risk of embolisation, rupture, or onset of ventricular arrhythmias. The diagnosis is based on standard cardiac imaging and symptoms are very rare. In this case report we illustrate our experience with a 81 years old female patient suffering from symptomatic aortic valve stenosis, respiratory disease, chronic renal failure and severe peripheral vascular disease (logistic euroscore: 42%), who successfully underwent a transapical 23 mm balloon-expandable stent-valve implantation through an apical diverticulum of the left ventricle. Intra-luminal thrombi were absent and during the same procedure were able to treat the valve disease and to successfully exclude the apical diverticulum without complications and through a mini thoracotomy. To the best of our knowledge, this is the first time that a transapical procedure is successfully performed through an apical diverticulum.

Transapical aortic valve replacement in extreme-risk patients: outcome, risk factors and mid-term results.

OBJECTIVES: Transcatheter aortic valve replacement (TAVR) provides good results in selected high-risk patients. However, it is unclear whether this procedure carries advantages in extreme-risk profile patients with logistic EuroSCORE above 35%. METHODS: From January 2009 to July 2011, of a total number of 92 transcatheter aortic valve procedures performed, 40 'extreme-risk' patients underwent transapical TAVR (TA-TAVR) (EuroSCORE above 35%). Variables were analysed as risk factors for hospital and mid-term mortality, and a 2-year follow-up (FU) was obtained. RESULTS: The mean age was: 81 ± 10 years. Twelve patients (30%) had chronic pulmonary disease, 32 (80%) severe peripheral vascular disease, 14 (35%) previous cardiac surgery, 19 (48%) chronic renal failure (2 in dialysis), 7 (17%) previous stroke (1 with disabilities), 3 (7%) a porcelain aorta and 12 (30%) were urgent cases. Mean left ventricle ejection fraction (LVEF) was 49 ± 13%, and mean logistic EuroSCORE was 48 ± 11%. Forty stent-valves were successfully implanted with six Grade-1 and one Grade-2 paravalvular leakages (success rate: 100%). Hospital mortality was 20% (8 patients). Causes of death following the valve academic research consortium (VARC) definitions were: life-threatening haemorrhage (1), myocardial infarction (1), sudden death (1), multiorgan failure (2), stroke (1) and severe respiratory dysfunction (2). Major complications (VARC definitions) were: myocardial infarction for left coronary ostium occlusion (1), life-threatening bleeding (2), stroke (2) and acute kidney injury with dialysis (2). Predictors for hospital mortality were: conversion to sternotomy, life-threatening haemorrhage, postoperative dialysis and long intensive care unit (ICU) stay. Variables associated with hospital mortality were: conversion to sternotomy (P = 0.03), life-threatening bleeding (P = 0.02), acute kidney injury with dialysis (P = 0.03) and prolonged ICU stay (P = 0.02). Mean FU time was 24 months: actuarial survival estimates for all-cause mortality at 6 months, 1 year, 18 months and 2 years were 68, 57, 54 and 54%, respectively. Patients still alive at FU were in good clinical condition, New York Heart Association (NYHA) class 1-2 and were never rehospitalized for cardiac decompensation. CONCLUSIONS: TA-TAVR in extreme-risk patients carries a moderate risk of hospital mortality. Severe comorbidities and presence of residual paravalvular leakages affect the mid-term survival, whereas surviving patients have an acceptable quality of life without rehospitalizations for cardiac decompensation.

Transaortic transcatheter aortic valve replacement with the Sapien? valve and the first generations of Ascendra?.

Traditionally, the transcatheter aortic valve replacement is performed through a transapical, a transfemoral or a trans-subclavian approach. Recently, the transaortic approach for transcatheter aortic valve replacement through the distal part of the ascending aorta was successfully implemented in order to avoid peripheral vascular access-related complications and apical life-threatening haemorrhage. The Sapien? stent valve has great transaortic potential because it can be loaded 'upside down' in different generations of delivery systems. However, because of their health regulatory systems and despite the launch, in 2012, of the latest generation of the Ascendra? delivery system, the Ascendra+?, specifically designed for transapical and transaortic valve placements, several countries are still using the first generations of Ascendra? (Ascendra? 1 and 2). This device was specifically designed for transapical procedures, and retrograde stent-valve positioning through the stenotic aortic valve may be very challenging and risk the integrity of the aorta. We describe the manoeuvre required in order to pass the stenotic aortic valve safely in a retrograde direction using the Sapien? stent valve and the first generations of Ascendra?.

Transcatheter aortic valve replacement for degenerative bioprosthetic surgical valves: results from the global valve-in-valve registry.

BACKGROUND: Transcatheter aortic valve-in-valve implantation is an emerging therapeutic alternative for patients with a failed surgical bioprosthesis and may obviate the need for reoperation. We evaluated the clinical results of this technique using a large, worldwide registry. METHODS AND RESULTS: The Global Valve-in-Valve Registry included 202 patients with degenerated bioprosthetic valves (aged 77.7±10.4 years; 52.5% men) from 38 cardiac centers. Bioprosthesis mode of failure was stenosis (n=85; 42%), regurgitation (n=68; 34%), or combined stenosis and regurgitation (n=49; 24%). Implanted devices included CoreValve (n=124) and Edwards SAPIEN (n=78). Procedural success was achieved in 93.1% of cases. Adverse procedural outcomes included initial device malposition in 15.3% of cases and ostial coronary obstruction in 3.5%. After the procedure, valve maximum/mean gradients were 28.4±14.1/15.9±8.6 mm Hg, and 95% of patients had ≤+1 degree of aortic regurgitation. At 30-day follow-up, all-cause mortality was 8.4%, and 84.1% of patients were at New York Heart Association functional class I/II. One-year follow-up was obtained in 87 patients, with 85.8% survival of treated patients. CONCLUSIONS: The valve-in-valve procedure is clinically effective in the vast majority of patients with degenerated bioprosthetic valves. Safety and efficacy concerns include device malposition, ostial coronary obstruction, and high gradients after the procedure.

Aortic root rupture: implications of catheter-guided aortic valve replacement.

PURPOSE OF REVIEW: The safety and efficiency of trans catheter aortic valve implantation (TAVI) has been clearly demonstrated. In high-risk patients, the number of procedures is constantly increasing and in western European countries this procedure is employed in more than 30% of isolated aortic valve replacements. The literature, however, focusing on perioperative aortic root (AoR) rupture is rather limited to just a few reports. The aim of this review is to analyze the pathophysiology of AoR rupture during TAVI, stressing the implications of the morphology of the AoR for this devastating complication. RECENT FINDINGS: Currently, perioperative AoR rupture ranges between 0.5 and 1.5% during TAVI, with almost 100% mortality. Recently, valve oversizing and balloon dilatation in a calcified and small AoR were considered as the most important predictive factors for this complication. SUMMARY: The most fragile unit of the AoR is its anchoring substrate to the ostium of the left ventricle. This membranous structure is not involved in the degenerative process leading to aortic valve stenosis. Due to the TAVI and/or balloon dilatation of the calcium stationed on the three leaflets and their attachment, a lesion may result on this structure. And, as a consequence, there is rupture of the AoR.