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.
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.
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.
To assess late outcome after transcatheter aortic valve implantation (TAVI) up to 6 years and to analyse its predictive factors with a particular emphasis on functional status. Very few data exist on ...the long-term results of TAVI, and these data are crucial for decision making.
Between October 2006 and December 2009, 123 consecutive patients were discharged alive after TAVI in our institution. Mean age was 82±8 years, and 88% of patients were highly symptomatic in New York Heart Association (NYHA) class III-IV.
Follow-up was complete in 122 patients (99%). The overall 6-year survival rate was 31%±5%, the majority of deaths being non-cardiac. Predictive factors of late mortality were the presence of lower limb arteritis (p=0.009), a higher Charlson comorbidity index (p=0.03) and post-TAVI paraprosthetic aortic regurgitation ≥2/4 (p=0.01). Late outcomes according to Valve Academic Research Consortium-2 criteria were analysed, and the 5-year event-free survival rate was 28%±4%. Finally, the rate of good functional results, defined as survival in NYHA class I or II, was 32%±5% at 5-year follow-up. In the survivors, the EQ-5D questionnaire further confirmed the benefit in terms of quality of life.
About one-third of patients discharged alive after TAVI were alive at 6-year follow-up, and the survivors exhibited good functional results assessed by NYHA class and quality-of-life standardised evaluation.
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.
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.
Emergency 3D-printing of medical devices came out as a potential solution to tackle shortages during the COVID-19 pandemic. Manufacturing medical devices in small series within hospitals is an ...exciting perspective in crisis management. Health professionals and additive manufacturing technology are ready for this revolution but regulative adaptations are still required. Here we present the design and production of a suture guide for cardiac surgery as a case study for a 3D-printed medical device manufactured during the COVID-19 pandemic.
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