Percutaneous repair of the tricuspid valve using a novel cinching device: acute and chronic experience in a preclinical large animal model.

AIMS: The aim of this study was to evaluate the safety, technical feasibility and performance of a new trans-catheter tricuspid repair system. METHODS AND RESULTS: Thirty-one adult swine underwent implantation of a transcatheter tricuspid remodelling system under general anaesthesia. The steerable transcatheter device was introduced through a 24 Fr femoral sheath into the right femoral vein and delivered to the tricuspid annulus on the beating heart. A fixation element was implanted into the tricuspid annulus. Following implantation, a second delivery system was used to couple the fixation element with a self-expanding nitinol stent. The device was tensioned to reshape the tricuspid valve and increase the coaptation length of the valve leaflets under echo guidance. Finally, the stent was deployed in the inferior vena cava (IVC) to maintain the tension applied. The transcatheter device was successfully implanted in all animals (n=31). Doppler echocardiography prior to sacrifice showed that tricuspid valve function was stable and normal tricuspid leaflet motion was observed. Cinching of the tricuspid annulus resulted in an increase of leaflet coaptation length of 70% (4.5±0.7 mm to 7.78±1.3 mm), an increase in trans-tricuspid peak velocity of 79% (0.38±0.1 m/s to 0.68±0.1 m/s), and a reduction in septolateral tricuspid valve dimension of 30% (35.2±5 mm to 24.8±5 mm). At necropsy, the fixation element was firmly attached to the annulus within a fibrotic tissue, with no coronary lesions observed and no abnormality visible. The stent was fully deployed in the IVC, without displacement or change in the stent shape. CONCLUSIONS: Percutaneous beating heart remodelling of the tricuspid annulus with a cinching device is safe and feasible.

Improving mitral valve coaptation with adjustable rings: outcomes from a European multicentre feasibility study with a new-generation adjustable annuloplasty ring system.

OBJECTIVES: To evaluate the performance and safety of an adjustable semi-rigid annuloplasty ring for mitral regurgitation (MR) in a multicentre study. METHODS: Between March 2010 and December 2011, 30 subjects underwent mitral valve (MV) repair using the Cardinal adjustable annuloplasty ring. This device is a semi-rigid ring allowing postimplantation size adjustment, under beating-heart conditions, to optimize leaflet coaptation under echocardiographic guidance. Coaptation length was determined before and after adjustment by transoesophageal echocardiography. RESULTS: The study enrolled 21 (70%) male and 9 (30%) female subjects with a mean age of 64 years. The approach was conventional midline sternotomy or mini-invasive right thoracotomy. Leaflet resection was done in 17 subjects, and chordal repair was used in 13. Concomitant procedures included coronary artery bypass grafting in 2 (7%) subjects, atrial ablation in 4 (13%) and tricuspid repair in 4 (13%). There was 1 (3%) early death unrelated to the study device. Intraoperative ring adjustment was performed in 24 of the 30 subjects. Residual MR was detected prior to adjustment in 6 subjects (4 mild and 2 moderate MR). Following adjustment, 5 subjects had no MR and 1 had trace MR. After adjustment, mean coaptation length improved from 7 ± 3 to 10 ± 3 mm (P < 0.0001). All patients who completed 1-year follow-up had less-than-mild MR, with the exception of 1 patient with ring dehiscence (and resultant 2+ MR) and 1 functional MR patient who developed recurrent 2+ MR due to persistent leaflet tethering. CONCLUSIONS: MV repair with the Cardinal adjustable annuloplasty ring is a reliable technique that enables the adjustment of the ring diameter on a beating heart under echocardiographic control. Such technology allows the optimization of leaflet coaptation, providing minimal residual MR and durable repair.

[Functional tricuspid regurgitation: the increasing clinical importance of the "forgotten valve"]. / L'insufficienza tricuspidale funzionale: un'entità clinica di crescente importanza.

Functional tricuspid regurgitation (FTR) is the most frequent etiology of tricuspid valve pathology in Western countries. In the last years, many investigators have reported evidence in favor of a more aggressive surgical approach to FTR and interest has been growing in the physiopathology and treatment of FTR. The purpose of this editorial is to explore the anatomical basis, pathophysiology, therapeutic approaches and the perspectives of treatment.

Direct access transcatheter mitral annuloplasty with a sutureless and adjustable device: preclinical experience.

OBJECTIVES: The aim of the study was to evaluate the technical feasibility and performance of a transcatheter mitral annuloplasty system. METHODS: Adult swines (n = 15) underwent left thoracotomy through the 4th-5th intercostal space. A transcatheter device (CardioBand, Valtech-Cardio Ltd) was introduced through an 18F sheath through the left atrium and attached to the annulus between the posterior and anterior commissures using echocardiographic and fluoroscopic guidance, on the beating heart. The sutureless device was implanted using a steerable delivery system to deploy sequential fixation elements. Following implantation, the device length was adjusted on the beating heart to reduce the intercommissural and septolateral dimension, under echocardiographic guidance. Finally, the flexible adjustment tool was withdrawn from the working sheath and the atrial purse-string closed. All but five animals were sacrificed acutely by intent, while the others were sacrificed at 90 days. RESULTS: All animals survived the acute implant. One animal died at the third post-operative day due to bleeding. The annuloplasty system was successfully implanted in all animals. A mean of 12 ± 3 fixation elements were deployed. The band length was reduced up to 20% after implantation in each animal. At necropsy, the location of the implant was within a few millimetres of the annulus (3.5 ± 4 mm). In three animals, fixation elements were implanted inadvertently in the leaflets, but no coronary lesions were observed. All animals survived the acute implant. One animal died on the third post-operative day due to bleeding. In the four long-term survivors, the implanted annuloplasty device showed satisfactory healing and no ring dehiscence. CONCLUSIONS: Transcatheter minimally invasive, beating-heart implantation of an adjustable annuloplasty band is feasible in the animal model. This approach may be an alternative to open surgical procedures in high-risk patients.

The growing clinical importance of secondary tricuspid regurgitation.

Functional or secondary tricuspid regurgitation (STR) is the most frequent etiology of tricuspid valve pathology in Western countries. Surgical tricuspid repair has been avoided for years, because of the misconception that tricuspid regurgitation should disappear once the primary left-sided problem is treated; this results in a large number of untreated patients with STR. Over the past few years, many investigators have reported evidence in favor of a more aggressive surgical approach to STR. Consequently, interest has been growing in the physiopathology and treatment of STR. The purpose of this review is to explore the anatomical basis, pathophysiology, therapeutic approach, and future perspectives with regard to the management of STR.

Beating-heart implantation of adjustable length mitral valve chordae: acute and chronic experience in an animal model.

OBJECTIVE: This study aimed to determine the acute and chronic performance of a new system designed to conduct beating-heart implantation and off-pump adjustment of neochordal length. METHODS: In 14 adult sheep (group A) selected to undergo beating-heart cardiopulmonary bypass, the left atrium was opened through a left thoracotomy. Two or more primary chordae in the A2 region were severed to produce a model of a flail leaflet. A chordal adjustment mechanism (V-Chordal, Valtech Cardio Ltd., Or-Yehuda, Israel) was affixed to the head of the papillary muscle. The system includes two adjustable neochordae. The distal end of the neochordae was sutured to the flail segment without estimating the appropriate length. The neochordal length was adjusted off-pump under real-time echo-guidance. The adjustment tool was removed and the atriotomy was closed with a purse-string suture. Control animals (group B, n=4) were implanted with the conventional neochordae. Animals in both groups were sacrificed 3 months after the procedure. RESULTS: In both groups, prior to repair, mitral regurgitation (MR) was severe in all animals. In group A, following adjustment of neochordae, MR was absent in all animals, with the exception of two animals that had residual 2+ MR irresponsive to neochordae adjustments. In group B, MR was 2+ in two of the four animals following repair. At 3 months, mitral competence was stable in all animals. At necropsy, normal healing of the papillary head and leaflet was observed in both the groups. CONCLUSIONS: The V-Chordal system simplifies the process of neochordal implantation and precise off-pump adjustment of the neochordal length to correct MR occurring due to a flail leaflet. This technology may improve the technical feasibility for adoption of chordal repair during open or minimally invasive surgical procedures.

Live broadcasting in cardiac surgery does not increase the operative risk.

OBJECTIVE: Live broadcasting of cardiac surgical procedures has an educational intention. There is an ongoing debate whether live surgery increases risk. Aim of this study was to evaluate the outcomes of patients who underwent a cardiac surgical procedure during live broadcasting. METHODS: A total of 250 cardiac operations were performed during 32 live broadcastings at four different clinical sites between 1999 and 2009. Data on patient characteristics, intra-operative procedures and patient short- and long-term outcome were collected and analyzed. All participating centers complied with the rules for the conduct of live surgery developed by the European Association of Cardiovascular and Thoracic Surgery (EACTS) Techno College Committee. RESULTS: Primary educational focus was the mitral valve in 126 cases, aortic valve including transcatheter valve implantations in 34, coronary artery bypass grafting (CABG) in 29, congenital in 26, aortic (ascending, arch, and descending) in 15, atrial fibrillation in 13, and heart failure in seven. Mean EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 8.7 ± 11.5 (range: 0.8-72). Thirty-day mortality was 1.2% (3/250): reasons for death were multi-organ failure in two and respiratory failure in one patient, respectively. Stroke rate was 2.4% (6/250). Five patients (2%) required cardiac re-operations within 30 days. The rate of mitral valve repair was 96% (121) and compares favourably with repair rates presented in national registries. Mean follow-up of all patients was 3.7 ± 2.8 years with an estimated survival of 92% (95% confidence interval (CI): 87-95%) at 5 years. CONCLUSIONS: Based on this large experience there is no evidence for an excess perioperative risk for patients operated under the conditions of live broadcasting.

Neochordae implantation made easy with an adjustable device: early report of acute and chronic animal experiments.

OBJECTIVE: Neochordae implantation is a well-established surgical solution for the treatment of mitral valve prolapse. The main limitation to wide usage of the technique has been the difficulty associated with accurate determination of neochordal length. We describe a system specifically designed to facilitate rapid, uncomplicated implantation and off-pump, beating heart adjustment of neochordae. METHODS: Five swine underwent implantation of the adjustable neochordal system (V-Chordal; Valtech Cardio LTD, Israel) while on cardiopulmonary bypass after cutting native chordae to create a significant lesion. Neochordae length was adjusted with millimeter-level resolution, off-pump after discontinuation from bypass. RESULTS: In all animals, the implant was successful. Under echocardiographic monitoring, flail lesions were corrected in all cases, using the anatomic landmarks or the degree of mitral regurgitation for real-time guidance. At postmortem gross examination, the implant and the neochordae were completely healed with evidence of tissue ingrowth. CONCLUSIONS: Preliminary animal experience suggests that the V-Chordal-adjustable neochordae system can be safely and effectively implanted, with accurate and precise adjustment of chordal length. The design of the device is suitable for a minimally invasive environment because of the long, flexible shafted design of the delivery system.

Right atrial tumor: a contraindication to minimally invasive surgery?

Cardiac tumors are rarely observed. The incidence of primary cardiac tumors in autopsy series ranges from 0.0017% to 0.19%. Surgical resection is the main therapy for the majority of the cardiac tumors. Surgical treatment of these tumors carries an operative mortality rate of 3% or less. In this article, we present our experience with a female patient, who had a right sided atrial tumor mimicking a myxoma. Port access surgery was performed through a small right sided "key-hole" working port in the fourth intercostal space. Extracorporeal circulation was conducted by femoro-femoral bypass and a kinetic assisted venous drainage system. Although, the safety and efficacy of port access approach have been well documented for resection of left atrial tumors in some series, use of this technique for right atrial tumor resection can be detrimental.

Tight perioperative glucose control is associated with a reduction in renal impairment and renal failure in non-diabetic cardiac surgical patients.

INTRODUCTION: Acute renal failure after cardiac surgery increases in-hospital mortality. We evaluated the effect of intra- and postoperative tight control of blood glucose levels on renal function after cardiac surgery based on the Risk, Injury, Failure, Loss, and End-stage kidney failure (RIFLE) criteria, and on the need for acute postoperative dialysis. METHODS: We retrospectively analyzed two groups of consecutive patients undergoing cardiac surgery with cardiopulmonary bypass between August 2004 and June 2006. In the first group, no tight glycemic control was implemented (Control, n = 305). Insulin therapy was initiated at blood glucose levels > 150 mg/dL. In the group with tight glycemic control (Insulin, n = 745), intra- and postoperative blood glucose levels were targeted between 80 to 110 mg/dL, using the Aalst Glycemia Insulin Protocol. Postoperative renal impairment or failure was evaluated with the RIFLE score, based on serum creatinine, glomerular filtration rate and/or urinary output. We used the Cleveland Clinic Severity Score to compare the predicted vs observed incidence of acute postoperative dialysis between groups. RESULTS: Mean blood glucose levels in the Insulin group were lower compared to the Control group from rewarming on cardiopulmonary bypass onwards until ICU discharge (p < 0.0001). Median ICU stay was 2 days in both groups. In non-diabetics, strict perioperative blood glucose control was associated with a reduced incidence of renal impairment (p = 0.01) and failure (p = 0.02) scoring according to RIFLE criteria, as well as a reduced incidence of acute postoperative dialysis (from 3.9% in Control to 0.7% in Insulin; p < 0.01). The 30-day mortality was lower in the Insulin than in the Control group (1.2% vs 3.6%; p = 0.02), representing a 70% decrease in non-diabetics (p < 0.05) and 56.1% in diabetics (not significant). The observed overall incidence of acute postoperative dialysis was adequately predicted by the Cleveland Clinic Severity Score in the Control group (p = 0.6), but was lower than predicted in the Insulin group (1.2% vs 3%, p = 0.03). CONCLUSIONS: In non-diabetic patients, tight perioperative blood glucose control is associated with a significant reduction in postoperative renal impairment and failure after cardiac surgery according to the RIFLE criteria. In non-diabetics, tight blood glucose control was associated with a decreased need for postoperative dialysis, as well as 30-day mortality, despite of a relatively short ICU stay.

Giant left coronary ostial aneurysm after modified Bentall procedure in a Marfan patient.

We performed surgical repair of a giant left coronary ostial aneurysm after aortic root replacement using composite valve graft (modified Bentall procedure) in a patient with Marfan syndrome. Aneurysmal formation in the left main stem itself is very rare. In order to avoid mobilizing the coronary ostium from severe adhesions after previous surgery and to reduce the tension on the anastomosis, the left main trunk was reconstructed using an interposition Dacron graft. In aortic root surgeries in Marfan patients, the size of the side hole on the composite graft should be kept relatively small to fit the diameter of the native coronary arteries for prevention of coronary buttons from forming aneurysms at the level of the coronary button anastomosis. In addition, close observation to the coronary button anastomosis is indispensable in postoperative check-up.

Excision of lipomatous hypertrophy of the interatrial septum via port-access.

We present the surgical resection and repair, using port-access, in a case of extensive lipomatous hypertrophy of the interatrial septum (IAS). There was tumourous lipomatous hypertrophy on the superior vena cava (SVC) - atrial junction close to the aortic root beside massive IAS hypertrophy. Resection of involved IAS and SVC was performed using bovine pericardium for the repair.

Myotomy through heart-port access for myocardial bridging.

We report a case of a 21-year-old man with a myocardial bridging of the left anterior descendens coronary artery associated with a regional systolic dysfunction of the left ventricle. Continuously elevated troponin levels suggested the presence of myocardial ischemia. Because of a tendency of worsening left ventricular systolic function, this myocardial bridge was treated by myotomy. Sternotomy could be avoided by doing the procedure with a heart-port access. The pathophysiology of myocardial bridging is incompletely understood. It is sometimes associated with overt pathology, as well as it can just be an incidental finding without any significance.

Endoscopic mitral and tricuspid valve surgery after previous cardiac surgery.

BACKGROUND: The purpose of this study was to evaluate the feasibility and effectiveness of a right video-assisted approach for atrioventricular valve disease after previous cardiac surgery. METHODS AND RESULTS: Between December 1st 1997 and May 1st 2006, 80 adults (mean age 65+/-12 years; 56% female) underwent reoperative surgery using a video-assisted approach without rib spreading. Previous cardiac operations included mitral valve (39%), CABG (29%), congenital (10%), and other (23%). For 25% of patients, this was at least their third cardiac operation. Mean time to redo surgery was 15+/-12 years. Femoral vessel cannulation and endoaortic clamping were routinely used. Mean preoperative Euroscore was 9.0+/-2.7 (5 to 20) and predicted mortality was 16.0+/-14.2% (4 to 86). Median preoperative NYHA class was II and mean follow-up was 25+/-22 months. Lung adhesions necessitated sternotomy in 4 cases and cannulation problems in another patient. Total operative mortality was 3.8% (n=3), O/E for mortality being 0.24. Procedures were mitral valve repair (45%; n=36), replacement (50%; n=40) and tricuspid valve replacement (5%; n=4). Additional procedures were performed in 44% (n=35). Mean aortic crossclamp and procedure time were 92+/-37 and 267+/-64 minutes. Mean postoperative blood loss was 815+/-1083 mL. Postoperative morbidity included 2 strokes (2.5%). Mean hospital stay was 10.7+/-6.7 days. Survival at 1 and 4 years was 93.6+/-2.8% and 85.6+/-6.4%. There was 1 late reoperation at 5 years. Median NYHA class at follow-up was II. When comparing, all but 1 patient (98.8%) preferred their minimally invasive approach when considering perioperative pain, postoperative rehabilitation, and final esthetic result. CONCLUSIONS: Video-assisted minimal access correction of atrioventricular valve disease after previous cardiac surgery is not only feasible but had lower than predicted mortality and strong patient satisfaction. It should therefore be used more frequently in today's practice.

Effect of mitral valve repair on exercise tolerance in asymptomatic patients with organic mitral regurgitation.

BACKGROUND: The aim of the study was to quantify the changes in cardiopulmonary function after minimally invasive video-assisted mitral valve repair for organic mitral regurgitation (MR) in asymptomatic or minimally symptomatic patients. METHODS: Twenty-six patients (age 54 +/- 11 years) with severe organic MR (regurgitant volume of 94 +/- 37 mL, effective regurgitant orifice [ERO] of 0.73 +/- 0.35 cm2) and mild or no symptoms (New York Heart Association class 1.2 +/- 0.4) underwent exercise echocardiography and cardiopulmonary exercise testing 1 week before and 4 months after uncomplicated video-assisted mitral valve repair. RESULTS: During exercise, left ventricular ejection fraction increased from 68% +/- 7% to 74% +/- 6% (P < .0001), but ERO did not change significantly. Four months after video-assisted mitral valve repair, a significant improvement was observed in peak oxygen uptake (VO2max from 23 +/- 6 to 25 +/- 7 mL x kg(-1) x min(-1), P < .001), peak oxygen pulse (11 +/- 3 to 12 +/- 4 mL per beat, P < .005) as well as in maximal workload (from 143 +/- 49 to 159 +/- 55 W, P < .0001). When only patients without any symptoms (New York Heart Association class I, n = 20) were considered, these changes were even more pronounced (VO2max from 24 +/- 7 to 27 +/- 7 mL x kg(-1) x min(-1), P < .001). Post-operative changes in VO2max correlated with preoperative exercise-induced contractile reserve (r = 0.72, P < .0001), preoperative ERO (r = 0.49, P < .05), and preoperative ejection fraction at rest (r = 0.42, P < .05). CONCLUSION: In patients with severe organic MR but mild or no symptoms, cardiopulmonary performance improves after successful minimally invasive video-assisted mitral valve repair. Improvement is directly related to preoperative left ventricular function and contractile reserve.

Endoscopic cardiac tumor resection.

BACKGROUND: The purpose of this study is to report our 9 years' experience with endoscopic cardiac tumor resection using the port access approach. METHODS: From March 1997 to December 2005, 27 patients (mean age, 56.2 +/- 16.9 years; 70% female) underwent endoscopic cardiac tumor resection using endocardiopulmonary bypass and endoaortic-balloon clamp technique. Nineteen (70%) patients presented in New York Heart Association class I, 4 patients presented with embolic stroke, and 4 patients presented with atrial arrhythmias. All patients underwent echocardiography on admission, intraoperatively, at discharge, and at follow-up evaluation. Eight patients additionally required mitral valve replacement (n = 1), tricuspid valve replacement (n = 1), mitral valve repair (n = 2), mini-maze (n = 1), and closure of patent foramen ovale (n = 3). Mean follow-up was 3.4 +/- 2.7 years. RESULTS: Mean endoaortic-balloon clamp and endocardiopulmonary bypass times were 68.8 +/- 30.8 minutes and 112.2 +/- 41.5 minutes, respectively. There were no conversions to sternotomy. Tumors resected were classified as left atrial myxoma (n = 20), right atrial myxoma (n = 3), lipoma (n = 1), intravenous leiomyoma involving the inferior vena cava and the tricuspid valve (n = 1), plexiform tumor of the sinoatrial node (n = 1), and papillary fibroelastoma of aortic valve noncoronary cusp (n = 1). There were no hospital deaths. Mean intensive care unit and hospital stays were 1.4 +/- 1.1 days and 7.3 +/- 3.4 days, respectively. Postoperative complications were evolving stroke (n = 1), re-exploration for bleeding (n = 1), and myocardial ischemia requiring stenting (n = 1). Follow-up failed to demonstrate residual or recurrent tumor. One patient had a small residual atrial septal defect. Ninety-two percent of patients appreciated the cosmetic result and fast recovery. CONCLUSIONS: Endoscopic cardiac tumor resection is feasible and a valid oncologic approach with an attractive cosmetic advantage over median sternotomy.

Endoscopic correction of the adult form of scimitar syndrome and mitral regurgitation: anatomic and technical considerations.

Scimitar syndrome is a congenital cardiac anomaly characterized by anomalous venous drainage of the right lung into the inferior vena cava. We report the combination of scimitar syndrome and mitral regurgitation and describe port-access correction for the adult form by means of an intraatrial baffle combined with mitral valve repair. Related considerations and modifications required in the standard Heartport (Cardiovations, Somerville, NJ) technique are discussed.

Avoiding vascular complications during minimally invasive, totally endoscopic intracardiac surgery.

OBJECTIVE: The introduction of minimally invasive valve surgery has been associated with an increased use of peripheral vessel cannulation in cardiopulmonary bypass. These techniques are associated with potential problems at the aorta or cannulation sites. The goal of this study was to review and describe our current practice to avoid vascular problems during cannulation of peripheral vessels. METHOD: Data collection for this study was done retrospectively by reviewing the files of all patients who underwent a minimally invasive mitral and/or tricuspid surgery in our institution from 1997 to the end of 2005. RESULTS: Our cohort of 978 patients revealed an overall rate of peripheral vascular complication of 1.0% with 44.4% presenting at the time of the surgery and 63.6% at long-term follow-up. Acute peripheral vascular problems were treated by simple graft replacement of the diseased segment in most cases. All aortic complications happened at the time of the surgery (complication rate of 0.9%) with 60% of them associated with cannulation problems. Most patients were treated by replacement of the ascending aorta. CONCLUSIONS: A systematic and careful approach is associated with a low risk of vascular problems. Prevention and planning with precise surgical technique remain the main conditions to safely use peripheral cannulation and perfusion for minimally invasive mitral valve surgery.