Quality of Life After Cardiac Operations Based on the Minimal Clinically Important Difference Concept.

BACKGROUND: Health-related quality of life (HRQOL) is an increasingly important issue in assessing the consequences of any surgical or medical intervention. Our study aimed to evaluate change in HRQOL 6 months after elective cardiac operations and to identify specific predictors of poor HRQOL. METHODS: In this prospective, single-center study, HRQOL was evaluated before and 6 months after the operation using the Medical Outcome Study 36-Item Short Form Health Survey questionnaire and its two components: the Physical Component Summary and the Mental Component Summary. We distinguished patients with worsening of HRQOL according to the minimal clinically important difference. All consecutive adult patients undergoing cardiac operations were included. RESULTS: The preoperative and postoperative 36-Item Short Form Health Survey questionnaires were completed by 326 patients, and 24 patients died before completing follow-up questionnaires. On the basis of the definition used, clinically significant deterioration of HRQOL was observed in 93 patients (26.6%) for the Physical Component Summary and in 99 patients (28.2%) for the Mental Component Summary. Renal replacement for acute renal failure and mechanical ventilation for longer than 48 hours were independent risk factors for Physical Component Summary and Mental Component Summary worsening or death. CONCLUSIONS: Although our study showed overall improvement of quality of life after cardiac operations, more than one-quarter of the patients manifested deterioration of HRQOL at 6 months postoperatively. The findings from this study should help clinicians to inform patients about their likely postoperative functional status and quality of life.

Proof of Concept of an Endoscopic Sutureless Valve Sizer.

OBJECTIVE: In this paper, we present an endoscopic expandable sizer conceived to allow thoracoscopic aortic valve replacement with a sutureless prosthesis using a dynamic sizing of the aortic annulus. METHODS: Ten aortic torsos were prepared using a five-trocar thoracoscopic setting. Once the aortotomy was performed and the aortic valve leaflets removed, the technical feasibility of the endoscopic sizing (introduction into the trocar, expansion into the aortic annulus, determination of the valve size, and retraction) with the device was assessed. In case of successful thoracoscopic sizing, endoscopic implantation of a sutureless valve (five LivaNova Perceval prosthesis and five Medtronic 3f Enable bioprosthesis) was performed. Before ascending aorta closure, we assessed the appropriate sealing of the bioprosthesis in the native annulus with camera visualization and a nerve hook inspection. RESULTS: All the 10 endoscopic sizings were technically feasible. The scheduled aortic sutureless valve implantations were successfully performed. In all cases, fitting and placement of the sutureless bioprosthesis in the flaccid heart was satisfactory, with no paraprosthetic leakage detectable by the nerve hook. CONCLUSIONS: The use of the endoscopic expandable sizer is technically possible. In this early-stage test in the flaccid heart, selection of the valve size was satisfactory during thoracoscopic sutureless aortic bioprosthesis implantation. Further laboratory evaluation with fluid dynamics (aortic root pressurization) will be performed before a clinical study is started.

First in Human Totally Endoscopic Perceval Valve Implantation.

Totally endoscopic cardiac operations for coronary procedures and atrial septal defect repair have demonstrated improved quality of life, but they have required longer cross-clamp times compared with open operations. Although transcatheter valve implantation remains appropriate for inoperable patients, the totally endoscopic approach could be an effective treatment for lower risk patients, including complete removal of the stenotic aortic valve, while minimizing surgical chest wall trauma, and providing excellent early quality of life. Totally endoscopic aortic valve replacement procedures were previously performed with the 3f Enable bioprosthesis. We present the first case, to our knowledge, of Sorin Perceval implantation.

Idiopathic Aortic Root to Right Atrial Fistula.

An aorta to right atrium fistula is rare. We report a case of idiopathic aortic root to right atrial fistula with right heart failure and review the literature. doi: 10.1111/jocs.12751 (J Card Surg 2016;31:373-375).

Closed chest human aortic valve removal and replacement: Technical feasibility and one year follow-up.

BACKGROUND: Minimally invasive aortic valve replacement has so far required a minithoracotomy or a ministernotomy. We present here the first series of totally endoscopic aortic valve replacement (TEAVR). METHODS: Between June 2013 and April 2015, 14 consecutive patients (12 males, mean age=76 ± 5.4 years) with a mean EuroSCORE II of 2.72 ± 0.03% underwent TEAVR. A five trocar setting was used in all patients: after ablation of the native valve, a Nitinol stented sutureless 3f Enable Medtronic valve, compressed into the main working trocar, was introduced into the thorax and then expanded in the aortic root. RESULTS: Among the 14 patients, a thoracoscopic approach was successful in 13 (92.8%) and conversion into an open surgery using the right anterior minithoracotomy was necessary to close the aortotomy in one case. Mean cross-clamping and cardiopulmonary (CPB) times were 112 ± 18 and 161 ± 31 min, respectively. All patients left the surgical unit within 8 days after the operation without any paravalvular leakage. There was no paravalvular regurgitation, conductive block or any major adverse event at a mean follow-up of 10 ± 4 months (range 2-16). CONCLUSIONS: TEAVR is feasible and safe in a selected subset of patients. Closed chest surgery has the potential to become the future approach of the isolated aortic valve replacement in low risk patients but further technical refinement and larger studies are necessary to reduce operative durations and enhance reproducibility.

Two Hundred Consecutive Implantations of the Sutureless 3f Enable Aortic Valve: What We Have Learned.

BACKGROUND: In this article we present a consecutive single-center experience of implantation of the Medtronic 3f Enable aortic valve (Medtronic Inc, Minneapolis, MN). METHODS: Between March 2011 and October 2014, 200 consecutive patients (mean age, 76.4 ± 5.9 years; logistic EuroScore, 7.8% ± 7.0%) in our unit received the 3f Enable valve. This is a retrospective analysis of this prospective monocentric cohort. RESULTS: The 3f Enable valve could be implanted in all the scheduled 141 isolated aortic valve replacement (AVR) procedures (14 full sternotomies, 73 ministernotomies, 44 minithoracotomies, and 10 thoracoscopic approaches) and 59 combined procedures (all using full sternotomy). Reclamping was necessary in 7 (3.5%) patients (paravalvular leakage [PVL] was ≥ grade 1 because of undersizing or prosthetic misalignment); mean cross-clamp and cardiopulmonary bypass (CPB) times were 65 ± 31 and 91 ± 39 minutes, respectively. Sixteen (8%) patients required early implantation of a pacemaker (PM). At a mean follow-up of 12.6 ± 8.1 months, mean transvalvular gradient and effective orifice area (EOA) were 9.8 ± 4.4 mm Hg and 1.87 ± 0.6 cm(2), respectively. Mild PVL was present in 7 (3.5%) patients and moderate PVL was present in 5 (2.5%) patients. No device migration was registered, and no moderate PVL was detected in the last 100 patients of the cohort. Overall, 3-year survival was 78%. CONCLUSIONS: The 3f Enable valve shows excellent results regarding PVL but in our experience required a learning curve and a refinement of the technique of implantation. Use of the prosthesis was possible in various less invasive approaches.

Sutureless aortic bioprosthesis valve implantation and bicuspid valve anatomy: an unsolved dilemma?

Interest is growing in the clinical use of sutureless (SU) valves. However, indications in some anatomical sub-settings, like bicuspid aortic valves (BAV), have been so far limited. We discuss herein our initial experience with the implantation of the 3f Enable SU bioprosthesis in patients with a BAV. Patients with a BAV were selected in our unit between March 2011 and September 2014 for a SU 3f Enable valve implantation. Twenty of the 198 patients who underwent a 3f Enable valve implantation in our unit had a BAV. Procedural success was 100 %, but reclamping was necessary in one (5 %) case. Median size of implanted bioprosthesis was 23 mm. After a mean follow-up of 13.8 ± 10.7 months, survival was 100 %. Two patients (10 %) showed an immediate grade 1 paravalvular leak (PVL) that progressed to grade 2 and 3+ (moderate/severe), respectively, during follow-up. Type of bicuspidy (Sievers classification) in these two patients was 0 and intraoperatively aortic annuli admitted the 25 mm calibrator. Among the 18 patients without PVL, no one had a type 0 large BAV. At 1 year, implantation of the 3f Enable SU bioprosthesis appears to be safe in patients with BAV type I and II, while in type 0 use of the SU valve seems to be safe only if the annular diameter is <25 mm. Larger studies are necessary to confirm our findings in order to clarify the indications for SU technology in the subset of bicuspid patients.

Robotic total endoscopic sutureless aortic valve replacement: proof of concept for a future surgical setting.

BACKGROUND: Sutureless valves have recently enabled closed chest aortic valve replacement. This paper evaluates the feasibility of a robotic telemanipulation during thoracoscopic sutureless aortic valve implantation in cadavers. METHODS: Cadavers were prepared with a five thoracosopic trocar setting, with a transthoracic clamp inserted in the first right intercostal space and the optics inserted in the second. Seven sutureless valve implantations were scheduled using 5 Sorin Perceval and 2 Medtronic 3f Enable valves. RESULTS: In all cases performance of pericardial suspension, aortotomy and root exposure required less than 20 min. Native valve excision and sutureless bioprosthesis implantation was technically feasible in all cases. A satisfactory prosthesis sealing was ascertained visually and the absence of paravalvular leakages was assessed with a nerve hook test around the prosthetic flange. CONCLUSIONS: Closed chest and robot assisted sutureless valve implantation is feasible in cadavers. Robotic technology can enhance reproducibility of the technique. Copyright © 2015 John Wiley & Sons, Ltd.

Sutureless 3f Enable Valve Implantation in a Failing Bio-Bentall Conduit.

We report the case of a 61-year-old man who underwent a Bentall procedure with a BioValsalva conduit for an acute type A aortic dissection. Two years later the patient presented at our institution with severe aortic regurgitation caused by the rupture of one cusp of the bioprosthesis (Elan valve) included in the conduit. A transcatheter valve-in-valve option was discussed by the heart team but was dismissed in favor of a sutureless 3f Enable valve implantation into the failing bioprosthesis after leaflet removal. This strategy simplified the surgical procedure and provided excellent postoperative hemodynamics at follow-up.

Sutureless 3F Enable Valve Replacement for Pure Aortic Regurgitation.

BACKGROUND AND AIM: We present our experience in the use of the sutureless valve in patients undergoing aortic valve replacement for pure aortic regurgitation. METHODS: Out of 167 patients who underwent sutureless aortic valve implantation with a Medtronic 3f Enable prosthesis in our unit between March 2011 and February 2014, 12 (7.1%) received a sutureless valve for pure aortic regurgitation. RESULTS: Mean age, logistic EuroSCORE, and left ventricular ejection fraction were 72 ± 5 years, 6.3 ± 2.9%, and 52.5 ± 15.3%, respectively. The sutureless valve could be successfully implanted in all cases; nine patients had a full sternotomy (associated coronary artery bypass graft in four cases and associated mitral surgery in five), one patient had a ministernotomy, and two had a thoracoscopic approach. Average cross-clamping and cardiopulmonary bypass times were 90 ± 30 and 127 ± 51 minutes, respectively. At the outpatient echocardiography, average mean gradient was 10.54 ± 4.99 mmHg and a grade I-II paravalvular leakage (PVL) was detected in the first patient of the cohort (ministernotomy approach). At a mean follow-up of 11.1 ± 5.5 months, average mean gradient was 9.75 ± 2.87 mmHg, no new PVL was detected, and the known PVL was stable. No pacemaker implantation was required. CONCLUSIONS: Implantation of the 3f Enable sutureless valve is technically possible with pure aortic regurgitation in selected patients. Multicenter investigations are necessary to assess the mid-term benefits of such a device in this subset of patients.

Sutureless Valve Implantation in Sievers Type 0 Bicuspid Annuli: A Word of Caution.

AIM: We describe a series of 3f Enable sutureless prostheses implanted in bicuspid valves. METHODS: Between March 2011 and April 2014, five patients with Sievers type 0 bicuspid valves were selected to receive the sutureless 3f Enable prosthesis . Exclusion criteria were: intraoperative calibration of the aortic annulus >27 mm, left ventricle ejection fraction <50%, age <70 years. RESULTS: All the implantations could be performed without the necessity to re-deploy the prosthesis . The perioperative transesophageal echocardiogragram detected two moderate paravalvular leakages (PVL) in two patients who received a large size of prosthesis (25 and 27 mm, respectively). The two leakages, at a follow-up of 32 and 24 months, respectively, increased to grade II and II +. No PVL appeared in the other three patients. CONCLUSION: This experience should warn about the inadequate performance of the 3f Enable valve in Sievers type 0 large aortic bicuspid annuli. In this subset any minor intraoperative residual leakage should not be accepted.

Mycoplasma hominis, a Rare but True Cause of Infective Endocarditis.

Mycoplasma spp. are rarely recognized agents of infective endocarditis. We report a case of Mycoplasma hominis prosthetic valve endocarditis diagnosed by 16S ribosomal DNA (rDNA) PCR and culture of valves in a 74-year-old man. We reviewed the literature and found only 8 other cases reported.

Sutureless 3f Enable valve implantation concomitant with mitral valve surgery.

OBJECTIVE: Interest in aortic sutureless bioprostheses is growing. Here, we evaluate the feasibility of performing aortic sutureless valve replacement concomitant with mitral valve surgery using the 3f Enable prosthesis. METHODS: Of the 198 3f Enable® valve implantation procedures carried out in our unit between March 2011 and October 2014, 15 were performed concomitant with mitral valve surgery (8 bioprosthetic replacements and 7 annuloplasties). RESULTS: The mean age and logistic EuroSCORE were 76 ± 6 years and 10.2 ± 4.8, respectively. The procedural success rate of aortic sutureless valve implantation was 100%. Mean cross-clamping and cardiopulmonary bypass times were 113.9 ± 35 and 150- ± 43 min, respectively. No reclamping in response to a sutureless paravalvular leakage (PVL) was needed. One grade 1 leak was observed at the time of discharge. There was no perioperative mortality. Pacemaker implantation was required in 1 case (6.6%). Initial follow-up (median = 8 months, range 1-6) showed no new aortic PVL; mean and peak transprosthetic gradients and the orifice area were 11.1 ± 2.5 and 18.4 ± 4.9 mmHg and 1.7 ± 0.4 cm(2), respectively. One grade 2 and two grade 1 mitral valve leaks were detected following annuloplasty. CONCLUSIONS: 3f Enable® sutureless valve implantation combined with mitral valve surgery appears feasible and the results presented here are encouraging. This procedure has the potential to simplify surgery in a cohort of high-risk patients for whom transcatheter aortic valve replacement is not an effective option. Larger studies should be conducted to confirm these observations.

Total endoscopic sutureless aortic valve replacement: rationale, development, perspectives.

Transcatheter valve implantation is progressively becoming the first line option for high risk patients in the management of severe aortic valve stenosis. Surgery is likely to remain the gold standard treatment option for intermediate risk patients since it ensures ablation of the underlying pathology and the calcified aortic valvular tissue, which potentially can act as a nidus of chronic embolization and provoke neurocognitive dysfunction in this subset of active patients. The surgical approach is continually evolving, with sutureless technology having the potential to facilitate ministernotomy and minithoracotomy approaches. Furthermore, Nitinol stented models can be introduced through thoracoscopic trocars, enabling the evolution of totally endoscopic aortic valve replacement (TEAVR). We present herein the development of TEAVR, starting from the cadaver experience in our lab. We transitioned through a clinical minithoracotomy video-assisted experience until we finally could initiate a program of human sutureless TEAVR. The limitations of this approach, which is still in refinement, and possible innovative solutions in order to build up a quick and reproducible procedure are discussed.

Sutureless prostheses and less invasive aortic valve replacement: just an issue of clamping time?

BACKGROUND: Recently, sutureless aortic bioprostheses have been increasingly adopted to facilitate minimally invasive aortic valve replacement. We aimed at evaluating the impact of the transition from conventional bioprostheses to the routine use of the 3f Enable prosthesis (Medtronic ATS Medical, Minneapolis, MN) for aortic valve replacement through ministernotomy. METHODS: Between November 2009 and November 2012, 83 consecutive minimally invasive aortic valve replacement procedures were performed in our institution by the same surgeon through an upper T-shaped ministernotomy. The earliest 42 patients (group A) received a conventional bioprosthesis, and the later 41 patients (group B) received the sutureless 3f Enable valve. Aortic clamping and cardiopulmonary bypass times, early outcomes, and valve hemodynamics were compared. RESULTS: There was no statistical intergroup difference in baseline characteristics. In-hospital mortality was 1% (a single nonvalve-related death). Average aortic clamping times in group A and group B were, respectively, 85 ± 17 and 47 ± 11 minutes (p < 0.0001); the cardiopulmonary bypass time was 108 ± 21 and 69 ± 15 minutes, respectively (p < 0.0001). There were three paravalvular leakages in group A (grade I) and four in group B (two grade I, and two grade II); three pacemaker implantations occurred in group B (p = 0.07); mean transvalvular gradient at discharge was 16.9 ± 9.1 mm Hg in group A and 11.4 ± 4.3 mm Hg in group B (p = 0.0007). During follow-up (average 25.5 ± 12.9 months), one structural valve deterioration was registered in group A, and was treated with a valve-in-valve procedure. CONCLUSIONS: In our initial experience, the sutureless 3f Enable technology significantly reduced the clamping and cardiopulmonary bypass times, as well as the mean transvalvular gradient in aortic valve replacement through ministernotomy.

Endovascular repair of mitroaortic intervalvular fibrosa aneurysm after bentall surgery.

We report the first case of a successful transapical transcatheter treatment of a giant pseudoaneurysm originating from a rupture of the mitroaortic fibrosa that occurred 3 months after a Bentall procedure in a 81-year-old male patient. Because of the age of the patient and the location of the leak at the mitroaortic fibrosa, the risk of a conventional ascending aorta reoperation was considered too high, and a transcatheter approach was chosen. A transapical puncture was performed with a left minithoracotomy followed by a catheterization of the pseudoaneurysm neck and an 8-mm Amplatzer (St. Jude Medical, Saint Paul, MN, USA) device was delivered, resulting in a successful complete endovascular exclusion of the pseudo-aneurysmal sac.

Right anterior minithoracotomy aortic valve replacement with a sutureless bioprosthesis: Early outcomes and 1-year follow-up from 2 European centers.

BACKGROUND: A sutureless aortic valve can be inserted through a right anterior minithoracotomy (RAMT) with consistent decreased cross-clamping time and ease of insertion. We report the experience of RAMT implantation of the 3f Enable (Medtronic, Inc, Minneapolis, Minn) self-expanding sutureless bioprosthesis, performed in 2 European cardiac surgery centers. METHOD: From September 2012 to April 2014, a total of 71 patients with severe aortic stenosis were selected to receive an aortic valve replacement via RAMT using the sutureless valve. Hemodynamic parameters and clinical outcome were assessed at discharge and up to 16 months postoperatively. RESULTS: All the patients received the prosthesis with success. One conversion to median sternotomy was necessary, owing to severe pleural adhesions. Overall in-hospital mortality was 2.8%. Mean cardiopulmonary bypass and cross-clamping time were, respectively, 91 ± 29 minutes and 66 ± 19 minutes. Reclamping was necessary in 4 cases (5.6%). Early incidences of grade I or lower paravalvular leakages and pacemaker implantation were, respectively, 4.2% and 5.6%. No paravalvular leakage greater than grade I was registered. The mean follow-up time was 8.1 months; the mean transvalvular gradient was, at discharge and at 6-12 months, respectively, 10.7 ± 4.3 mm Hg and 9.6 ± 3.1 mm Hg. The degree of regurgitation remained stable in all cases. Freedom from all-cause and valve-related mortality was 97% and 99%, respectively, at 1 year. CONCLUSIONS: Aortic valve replacement via RAMT with the 3f Enable valve is a reproducible procedure, as it provides satisfactory hemodynamics, and a low valve-related complication rate. Greater experience is needed to compare the performance of the 3f Enable valve with that of other sutureless valves implanted via the same RAMT procedure.