Prospective US investigational device exemption trial of a sutureless aortic bioprosthesis: One-year outcomes.

OBJECTIVES: We performed a prospective, single-arm clinical trial approved under a Food and Drug Administration Investigational Device Exemption to assess safety and efficacy of Perceval, a sutureless bovine pericardial aortic valve representing the initial US experience. METHODS: From June 2013 to January 2015, 300 patients (mean age 76.7 ± 7.7 years, 54.3% men, 37.3% ≥80 years, median Society of Thoracic Surgeons Predicted Risk of Mortality 2.8%), underwent Perceval valve implantation at 18 centers across the United States. Twenty patients (6.7%) had a bicuspid aortic valve and 5 (1.7%) patients had previous aortic valve replacement. A minimally invasive approach was used in 80 (26.7%) and concomitant procedures were performed in 113 (37.8%) patients. RESULTS: Two hundred eighty-nine patients (96.3%) were successfully implanted. Operative mortality (≤30 days) was 1.3% (n = 4) (observed to expected ratio of 0.40). One-year results included all-cause mortality in 5.2% (n = 15), stroke in 1% (n = 3), and endocarditis in 1.7% (n = 5). New permanent periprocedural pacemaker rate was 10.7% (n = 30/281); 2.5% (n = 7/281) resulted from third-degree atrioventricular block. One-year valve-related reoperation was 2.1% (n = 6). At 1-year follow-up, 98% of patients were in New York Heart Association class I/II, left ventricular mass index decreased from 103.5 ± 30.1 g/m2 at discharge to 95.8 ± 27.1 g/m2 (P = .001), and 3 (1.3%) moderate paravalvular leaks were identified. Health-related quality of life score increased from 62.7 ± 21.8 before surgery to 85.5 ± 17.8 at 1 year (P < .001). CONCLUSIONS: These results confirm the safety and effectiveness of the Perceval sutureless aortic valve replacement in study patients with lower mortality than expected from a risk prediction model. Persistent hemodynamic benefit and improvement in quality of life at 1 year support the importance of this device in the management of aortic valve disease.

A new mitral valve repair strategy for hypertrophic obstructive cardiomyopathy.

BACKGROUND AND AIM OF THE STUDY: Previously, surgery hypertrophic obstructive cardiomyopathy (HOCM) has consisted primarily of septal myectomy and/or resection of the anterior mitral leaflet with low-profile valve replacement. However, recent studies have shown that the anterior papillary muscle and chordal fan can contribute to obstruction, and also that significant mitral regurgitation (MR) may be encountered. Hence, a surgical procedure was devised to address all components of this disorder. METHODS: A 37-year-old man had a history of heart murmur and NYHA class IV symptoms, despite beta-blocker therapy. Echocardiography showed severe septal hypertrophy, systolic anterior motion (SAM) of the mitral valve, severe MR and a 185 mmHg resting outflow tract gradient. At surgery, the anterior papillary muscle was found to be medially displaced and contributing to outflow obstruction. The anterior papillary muscle and chordae were resected, a 'traditional' septal myectomy was performed, and a full annuloplasty ring placed. The mitral valve was repaired by connecting the left aspect of the leaflets to the posterior papillary muscles, using Gore-Tex artificial chords. RESULTS: The patient recovered uneventfully. Interval echocardiography at one year showed a negligible outflow gradient, relief of SAM and mild residual MR. The patient currently is active, essentially asymptomatic, and not receiving any medical therapy. CONCLUSION: Previous approaches to HOCM have been limited by a small incidence of recurrent outflow gradients, pacemaker requirement, persistent MR or complications of the prosthetic valves. By comprehensively addressing all components of outflow obstruction and mitral dysfunction, this combined procedure may produce better results in certain subsets of HOCM, with the excellent late prognosis of artificial chordal replacement.

Robotically assisted, completely endoscopic transmyocardial revascularization is feasible.

OBJECTIVE: The purpose of this study was to assess the feasibility of an endoscopic, optical-fiber-based, laser delivery system (LDS) developed to perform sole-therapy transmyocardial revascularization (TMR) in a totally endoscopic, robotically assisted operation. METHODS: Forty-two patients were enrolled in a multicenter, prospective, single-arm clinical trial conducted at four US centers between 2005 and 2007. Transmyocardial revascularization was performed completely endoscopically with robotic assistance, introducing the Holmium:Yttrium aluminum garnet (YAG) LDS via a 5-mm port. Completion of the operation endoscopically defined procedural success. Clinical data were recorded before, during, and at least 30 days after the procedure. RESULTS: All patients had Canadian Cardiovascular Score angina class IV at baseline. The mean ejection fraction was 49% (range [R], 28-71), the mean age was 59.1 years (R, 36-80), 71% (30/42) were men, 86% (36/42) underwent previous coronary artery bypass grafting surgery, and 76% (32/42) underwent prior coronary stenting. Procedural success was accomplished in 93% (39/42). For the procedural successes, the mean number of TMR channels was 32 (R, 16-50), the median operative time was 88 minutes (R, 48-250 minutes), and the median length of stay postoperatively was 2.5 days (R, 1-10). There was no operative or 30-day mortality, and no patient received any transfusion. At 30 days, freedom from major adverse cardiac events was 95% (two patients had transient congestive heart failure). At the median 6-month follow-up (single-center data, n = 12), the mean (SD) Canadian Cardiovascular Score angina score was 1.3 (0.05) (P < 0.001 vs baseline). CONCLUSIONS: Robotically assisted TMR can be performed using an endoscopic, optical-fiber-based LDS, with high procedural success, avoidance of early adverse clinical events, and potential for successful angina relief.

Hot shot induction and reperfusion with a specific blocker of the es-ENT1 nucleoside transporter before and after hypothermic cardioplegia abolishes myocardial stunning in acutely ischemic hearts despite metabolic derangement: hot shot drug delivery before hypothermic cardioplegia.

OBJECTIVE: Simultaneous inhibition of the cardiac equilibrative-p-nitrobenzylthioinosine (NBMPR)-sensitive (es) type of the equilibrative nucleoside transport 1 (ENT1) nucleoside transporter, with NBMPR, and adenosine deaminase, with erythro-9-[2-hydroxy-3-nonyl]adenine (EHNA), prevents release of myocardial purines and attenuates myocardial stunning and fibrillation in canine models of warm ischemia and reperfusion. It is not known whether prolonged administration of hypothermic cardioplegia influences purine release and EHNA/NBMPR-mediated cardioprotection in acutely ischemic hearts. METHODS: Anesthetized dogs (n = 46), which underwent normothermic aortic crossclamping for 20 minutes on-pump, were divided to determine (1) purine release with induction of intermittent antegrade or continuous retrograde hypothermic cardioplegia and reperfusion, (2) the effects of postischemic treatment with 100 µM EHNA and 25 µM NBMPR on purine release and global functional recovery, and (3) whether a hot shot and reperfusion with EHNA/NBMPR inhibits purine release and attenuates ventricular dysfunction of ischemic hearts. Myocardial biopsies and coronary sinus effluents were obtained and analyzed using high-performance liquid chromatography. RESULTS: Warm ischemia depleted myocardial adenosine triphosphate and elevated purines (ie, inosine > adenosine) as markers of ischemia. Induction of intermittent antegrade or continuous retrograde hypothermic (4°C) cardioplegia releases purines until the heart becomes cold (<20°C). During reperfusion, the levels of hypoxanthine and xanthine (free radical substrates) were >90% of purines in coronary sinus effluent. Reperfusion with EHNA/NBMPR abolished ventricular dysfunction in acutely ischemic hearts with and without a hot shot and hypothermic cardioplegic arrest. CONCLUSIONS: Induction of hypothermic cardioplegia releases purines from ischemic hearts until they become cold, whereas reperfusion induces massive purine release and myocardial stunning. Inhibition of cardiac es-ENT1 nucleoside transporter abolishes postischemic reperfusion injury in warm and cold cardiac surgery.

Increasing mitral valve repair rates with nonresectional techniques.

In every common mitral pathology studied to date, repairing the patient's own diseased valve to adequate function has yielded superior long-term results as compared with prosthetic valve replacement with either tissue or mechanical devices. Thus, increasing rates of mitral repair across all valve pathologies would seem to be a logical clinical goal. Techniques for mitral valve repair have undergone continual evolution over the past 50 years. Recently, emphasis has been placed on preserving leaflet surface area and avoiding tissue resection, by combining the methods of Gore-Tex artificial chordal replacement, autologous pericardial leaflet augmentation, and full ring annuloplasty. Using combinations of these three techniques appropriate to the given valve pathology, acute mitral repair rates now are approximating 98% for all common mitral disease etiologies. Simultaneously, operative mortalities for mitral repair have fallen significantly and now are negligible, whereas long-term outcomes using these methods have been increasingly more stable. As a result of innovations from multiple sources, mitral valve surgery has been converted from a higher risk procedure to one of the safest operations in most centers. This review will detail the technical application of "nonresectional" mitral repair approaches to a broad range of mitral disease pathologies.

Robotic artificial chordal replacement for repair of mitral valve prolapse.

Artificial chordal replacement (ACR) has emerged as a superior method of mitral valve repair with excellent early and late efficacy. It is also ideal to combine with robotic techniques for correction of mitral prolapse, and this article presents a current method of robotic Gore-Tex ACR. Patients with isolated posterior leaflet prolapse are approached with the fourth-generation DaVinci robotic system and endoaortic balloon occlusion. A pledgetted anchor stitch is placed in a papillary muscle, and a 2-o Gore-Tex suture is passed through the anchor pledget. After full annuloplasty ring placement, the Gore-Tex suture is woven into the prolapsing segment and positioned temporarily with robotic forceps. Chordal length is then "adjusted" by lengthening or shortening the temporary knot over 1-cm increments as the valve is tested by injection of cold saline into the ventricle. After achieving good leaflet position and valve competence, the chord is tied permanently. The "adjustable" ACR procedure preserves leaflet surface area and produces a competent valve in the majority of patients. Postoperative transesophageal echo shows a large surface area of coaptation. Patient recovery is facilitated by the minimally invasive approach, while long-term stability of similar open ACR techniques have been excellent with a 2% to 3% failure rate over 10 years of follow-up. Robotic Gore-Tex ACR without leaflet resection is a reproducible procedure that simplifies mitral repair for prolapse. The outcomes observed in early robotic applications have been excellent. It is suggested that most patients with simple prolapse might validly be approached in this manner.

Totally endoscopic robot-assisted transmyocardial laser revascularization.

We describe the first use of totally endoscopic, off-pump, robot-assisted transmyocardial laser revascularization in a 58-year-old man with refractory rest angina who had undergone two prior coronary bypass operations. Preoperative testing revealed reversible ischemia of the left ventricular apex with diffuse coronary atherosclerotic disease not suitable for further treatment by conventional techniques. During surgery a fiberoptic laser delivery system was manipulated using the da Vinci robotic system to create 25 transmural channels in the left ventricular myocardium. Postoperative recovery was rapid and uneventful, with complete relief of anginal symptoms at 30 days.