Abstract Objectives This study sought to evaluate the feasibility of transfemoral transcatheter heart valve (THV) implantation in failed mitral bioprostheses and ring annuloplasties. Background Redo ...mitral surgery may be high risk or contraindicated due to comorbidity. THV implantation has been recently reported in this setting. Methods Transfemoral implantation of Edwards Sapien prosthesis was performed in 17 patients for degenerated mitral bioprosthesis or previous ring annuloplasty (6 bioprostheses, 11 ring annuloplasties). The procedure was elective for 14 patients and attempted as a rescue in 3 patients. Mean age was 61 ± 24 years. All patients were in New York Heart Association class ≥III, and the surgical risk was high (EuroSCORE European System for Cardiac Operative Risk Evaluation: 37 ± 29%, Society of Thoracic Surgeons score: 18 ± 22%). Results Procedure was successful in 14 patients (82%). Two complications occurred during rescue procedures: 1 procedural death and 1 THV migration. One patient had moderate paraprosthetic regurgitation following the procedure, whereas residual regurgitation was trace or less in 11 patients (69%) and mild in 4 patients (25%). Mean gradient decreased from 12 ± 6 mm Hg to 8 ± 3 mm Hg. During a mean follow-up of 22 months, 4 patients died, 3 from cardiac cause. The 18-month survival was 68 ± 14% in the overall population and 78 ± 14% for patients with elective procedure. One patient underwent mitral valve replacement due to periprosthetic mitral regurgitation. At last follow-up, 12 patients were in New York Heart Association class ≤II (75%) and 4 in class III (25%). Conclusions This single-center series suggests that transfemoral THV implantation for deterioration of mitral bioprosthesis or surgical repair is feasible in selected patients and improves early hemodynamic and midterm functional status.
Our study objective was to assess the incidence, predictors, and implications of access site complications related to transfemoral transcatheter aortic valve implantation (TAVI). We pooled the ...prospective TAVI databases of 5 experienced centers in Europe enrolling only transfemoral cases for this analysis. Access site complications were defined according to the Valve Academic Research Consortium end-point definitions. The global transfemoral TAVI database contained 986 patients. Percutaneous access and closure was performed in 803 patients (81%) and a surgical strategy in 183 (19%). Incidences of major vascular complications, life-threatening/disabling bleeding, and major bleeding were 14.2%, 11%, and 17.8% respectively. In the patient cohort with a completely percutaneous access strategy, major vascular complications and life-threatening/disabling bleedings were related to closure device failure in 64% and 29%, respectively. Female gender (odds ratio 1.63, 95% confidence interval 1.12 to 2.36) and use of >19Fr system (2.87, 1.68 to 4.91) were independent predictors for major vascular complications. Female gender (odds ratio 2.04, 95% confidence interval 1.31 to 3.17), use of >19Fr system (1.86, 1.02 to 3.38), peripheral arterial disease (2.14, 1.27 to 3.61), learning effect (0.45, 0.27 to 0.73), and percutaneous access strategy (2.39, 1.16 to 4.89) were independently associated with life-threatening/disabling bleedings. In conclusion, transfemoral TAVI is associated with a >10% incidence of major vascular-related complications. A considerable number of these events is related to arteriotomy closure failure. Arterial sheath size and female gender are important determinants of major vascular complications and life-threatening/disabling bleeding.
Objectives We sought to describe the results of a strategy offering either transfemoral or transapical aortic valve implantation in high-risk patients with severe aortic stenosis. Background Results ...of transfemoral and transapical approaches have been reported separately, but rarely following a uniform assessment to select the procedure. Methods Of 160 consecutive patients at high risk or with contraindications to surgery, referred between October 2006 and November 2008, 75 were treated with transcatheter aortic valve implantation. The transfemoral approach was used as the first option and the transapical approach was chosen when contraindications to the former were present. The valve used was the Edwards Lifesciences SAPIEN prosthesis. Results Patients were age 82 ± 8 years (mean ± SD), in New York Heart Association functional classes III/IV, with predicted mean surgical mortalities of 26 ± 13% using the European System for Cardiac Operative Risk Evaluation and 16 ± 7% using the Society of Thoracic Surgeons Predicted Risk of Mortality. Fifty-one patients were treated via the transfemoral approach, and 24 via the transapical approach. The valve was implanted in 93% of the patients. Hospital mortality was 10%. Mean (± SD) 1-year survivals were 78 ± 6% in the whole cohort, 81 ± 7% in the transfemoral group, 74 ± 9% in the transapical group (p = 0.22), and 60 ± 10% in the first 25 patients versus 93 ± 4% in the last 50 patients treated (p = 0.001). In multivariate analysis, early experience was the only significant predictor of late mortality. Conclusions Being able to offer either transfemoral or transapical aortic valve implantation, within a uniform assessment, expands the scope of the treatment of aortic stenosis in high-risk patients and provides satisfactory results at 1 year in this population. The results are strongly influenced by experience.
Abstract Objectives This study sought to describe the results of transcatheter tricuspid valve-in-ring (TVIR) implantation for treatment of tricuspid regurgitation (TR). Background Off-label use of ...transcatheter valves within surgically placed tricuspid annuloplasty prostheses has only been described in small reports. An international multicenter registry was developed to collect data on TVIR implantation. Methods Data were collected from 13 sites on 22 patients (5 to 69 years of age) with TR who underwent catheterization with the intent to perform TVIR implantation. Results TVIR implantation was performed in 20 patients (91%). Most patients were severely impaired (86% in New York Heart Association functional class III or IV); TR was severe in 86%. A Sapien valve (Edwards Lifesciences, Irvine, California) was implanted in 17 patients and a Melody valve (Medtronic, Minneapolis, Minnesota) in 3. There were no procedural deaths. There was 1 valve embolization requiring retrieval and placement of second TVIR implant and 1 valve malposition with severe paravalvular regurgitation requiring a second TVIR implantation. Over a median follow-up of 12 months, 1 patient died and 2 underwent repeat TVIR implantation, 1 of whom subsequently underwent surgical valve replacement. Significant paravalvular leak (PVL) was treated at the time of TVIR implantation in 4 patients: 3 underwent device occlusion and 1 received a second TVIR implant. On follow-up echocardiography, 15 patients had PVL (75%), the majority of which (n = 10) were trivial or mild and did not require treatment. PVL intervention was performed in 3 patients during follow-up. Functional capacity improved in most patients (70%). Conclusions TVIR implantation using commercially available transcatheter prostheses is technically feasible and clinically effective in reducing TR. Paravalvular regurgitation is common and may necessitate further interventions.
Little is known about transcatheter aortic valve implantation (TAVI) in patients with bicuspid aortic valve stenosis, which usually represents a contraindication. The aim of this study was to assess ...the feasibility and the results of TAVI in this patient subset. Of 316 high-risk patients with severe aortic stenosis who underwent TAVI from January 2009 to January 2012, 15 (5%) had documented bicuspid aortic valves. They were treated using a transarterial approach, using the Medtronic CoreValve system. Patients were aged 80 ± 10 years, in New York Heart Association functional classes III and IV. The mean aortic valve area was 0.8 ± 0.3 cm2 , and the mean gradient was 60 ± 19 mm Hg. The mean calcium score, calculated using multislice computed tomography, was 4,553 ± 1,872 arbitrary units. The procedure was successful in all but 1 patient. Major adverse events, according to Valvular Academic Research Consortium definitions, were encountered in 1 patient (death). The mean postimplantation prosthetic gradient was 11 ± 4 mm Hg, and ≤1+ periprosthetic leaks were observed in all but 2 patients. The mean prosthetic ellipticity index was 0.7 ± 0.2 at the level of the native annulus and 0.8 ± 0.2 at the level of the prosthetic leaflets. After a mean follow-up period of 8 ± 7 months, 1 patient had died from aortic dissection; there were no additional adverse events. All but 2 hospital survivors were in New York Heart Association class I or II. In conclusion, the present series suggests that transarterial Medtronic CoreValve implantation is feasible in selected patients with bicuspid aortic valve and may lead to short-term hemodynamic and clinical improvement.
Patient #3 was a 66-year-old woman with morbid obesity, renal failure, prior AVR, post-endocarditis mitral regurgitation (MR) with chordal rupture, and failure of surgical valve repair due to ...extensive MAC (Figure 1, panel 3A). In Patient #2, the 26-mm valve seemed too high in the mitral annulus. ...a second 26-mm valve was implanted into the first valve in a more appropriate ventricular position (Figure 1, panel 2B).
Objective To describe differences in intra- and postoperative care between general (GA) and local/regional anesthesia (LRA) in consecutive high-risk patients with aortic stenosis who underwent ...transfemoral transcatheter aortic valve implantation (TAVI). Design A retrospective review of data collected in an institutional registry. Setting An academic hospital. Participants One hundred twenty-five consecutive patients with severe aortic stenosis who underwent transfemoral TAVI. Interventions GA versus LRA followed by postoperative care. Complications were defined by pre-established criteria. Material and Methods Consecutive patients referred for transfemoral TAVI between October 2006 and October 2010 initially underwent GA (n = 91) followed by LRA after March 2010 (n= 34). Results are presented as mean ± standard deviation or median (25-75 percentiles) as appropriate. GA and LRA TAVI patients had similar preoperative characteristics. LRA was associated with a significantly shorter procedure duration (LRA: 80 67-102; GA: 120 90-140 minutes; p < 0.001), hospital stay (LRA: 8.5 7-14.5; GA: 15.5 10-24 days; p < 0.001), intraoperative requirements of catecholamines (LRA 23%; GA: 90% of patients; p < 0.001), and volume expansion (LRA: 11 8-16; GA: 22 15-36 mL/kg; p < 0.001). There were significant differences in delta creatinine (day 1, preoperative creatinine values; LRA: 0 −12 to 9; GA: −15 (−25 to 2.9) μmol, p < 0.004). The frequency of any postoperative complications was 38% (LRA) and 77% (GA) ( p = 0.11). Thirty-day mortality was 7% (GA) and 9% (LRA) ( p = 0.9). Conclusions This observational study suggests that LRA was associated with less intraoperative hemodynamic instability and significant shortening of the procedure and hospital stay. Changes in the anesthetic technique adapted to changes in TAVI interventional techniques and did not increase the rate of postoperative complications.
No evidence exists on the feasibility of transcatheter aortic valve replacement (TAVR) using balloon-expandable valves to treat pure aortic regurgitation (AR) on noncalcified native valves (NCNV). ...Patient #2 was an 87-year-old man with severe peripheral vascular disease and low left ventricular ejection fraction (20%).
Background Recent series have reviewed the results of transapical aortic valve implantation (TAVI). However, specific problems of this new procedure are not well-described. Unexpected complications ...due to the procedure and their management are reported. Methods Eighteen patients underwent TAVI using the Edwards Sapien bioprosthesis (Edwards Lifesciences Inc, CA) between September 2007 and June 2008 due to contraindications of conventional surgery (n = 5) or high operative risk (n = 13). The system was introduced through 2 purse string sutures in the apex under echocardiographic and fluoroscopic control. Results The implantation success rate and initial procedural success were 100%. There was no intraoperative death and no stroke. During the procedure, two cases of ventricular fibrillation consequent to rapid pacing were treated by cardioversion. Acute mitral regurgitation due to traction of the subvalvular apparatus by the guidewire and acute aortic regurgitation from pressure on a bioprosthesis cusp by the guidewire were diagnosed by transesophageal echocardiography and reversed by the removal of the guidewire. Another case of aortic regurgitation was due to incomplete deployment of the bioprosthesis and was managed by a “valve after valve” procedure. Two patients died on postoperative day 2 from left ventricular failure. In one patient the postmortem study showed, despite correct implantation of the bioprosthesis, a hematoma of the septum with a small ventricular septal defect. The total in-hospital death was 27.7% (5 patients). There was no periprocedural bleeding but in one patient delayed rupture of the apex (36 hours after the procedure) necessitated emergency surgery. A false aneurysm of the apex appeared 3 months after surgery in another patient. Closure of the apex was performed through sternotomy and cardiopulmonary bypass with an uneventful follow-up. Conclusions The TAVI is associated with incidents and complications different to those encountered in conventional aortic valve surgery. Recognizing their existence contributes to elucidating their mechanisms and to propose solutions to avoid or treat them.
Transcatheter mitral valve replacement (TMVR) is a therapeutic option for patients with contraindication or high risk for surgical treatment and failed surgical bioprosthesis or annuloplasty, or even ...calcific mitral valve disease (1,2). Two of the 3 patients discussed here were asymptomatic at diagnosis, and therefore, this complication may remain undiagnosed unless echocardiographic follow-up is systematically performed. ...only a mild increase of transmitral gradient was observed in 2 cases. ...thrombosis of a THV may be overlooked if only TTE is performed.