The Jarvik 2000 Left Ventricular Assist Device: Results of the United States Bridge to Transplant Trial.

The Jarvik 2000 bridge to transplant investigational device exemption study was a multicentered, prospective study of 150 UNOS status I patients implanted with the Jarvik 2000 between 2005 and 2012. During the study period, there were numerous modifications of the system that included converting from pin to cone bearings. Results were analyzed for three cohorts: total (n = 150), pin (n = 128), and cone (n = 22). Baseline demographics included age (52 ± 13), gender (79% male), size (BSA 1.98), and etiology (37% idiopathic dilated cardiomyopathy; 43% Ischemic). Seventy percent of patients were either INTERMACS 1 or 2. The primary endpoint-defined as successful transplantation or listing at 180 days (prespecified at 65%; 95% lower CI: 57%)-was successfully achieved for the total cohort (67.3%; 95% CI: 59.5%-74.3%; p = 0.006). In subgroup analysis of the more contemporary, cone-bearing group, the primary endpoint was met in 91% (95% CI: 72%-97.5%; p = 0.001). Compared with pin patients, cone-bearing patients had less hemolysis as well as decreased end-organ dysfunction. Functional and quality of life scores improved after implantation independent type of bearing. In conclusion, despite a particularly sick patient population, the Jarvik 2000 was shown to be effective in supporting the advanced HF patient.

Tricuspid valve repair for treatment and prevention of secondary tricuspid regurgitation in patients undergoing mitral valve surgery.

Secondary or functional tricuspid regurgitation occurring late after mitral valve surgery is associated with high morbidity and mortality. In this article, we review the pathophysiology of secondary tricuspid regurgitation and the evidence supporting the use of tricuspid valve annuloplasty for preventing and treating secondary tricuspid regurgitation. Liberal application of tricuspid valve annuloplasty is recommended to prevent progression of secondary regurgitation, as contrary to widely held opinion, fixing the left-sided valve dysfunction often does not resolve secondary tricuspid valve dysfunction. Based on existing literature, assessing the tricuspid valve annular dimensions can be recommended as part of all mitral valve operations, and annuloplasty strongly considered in patients with tricuspid annular dilatation or moderate to severe tricuspid regurgitation.

Etiologic classification of degenerative mitral valve disease: Barlow's disease and fibroelastic deficiency.

Barlow's disease and fibroelastic deficiency are the two dominant forms of degenerative mitral valve disease and have unique differentiating characteristics on clinical and echocardiographic assessment. Preoperative differentiation of patients by both cardiologists and surgeons is important because the techniques, surgical skill, and expertise required to achieve a repair vary among these etiological subsets. Barlow's patients often have multiple complex lesions, thus high rates of repair are only likely to be achieved by a reference mitral valve repair surgeon. In contrast, many forms of fibroelastic disease should be repaired at a high rate by experienced general cardiac surgeons. In this article, we highlight the differentiation of Barlow's disease and fibroelastic deficiency.

Unrealistic expectations arising from mortality data reported in the cardiothoracic journals.

BACKGROUND: This study was undertaken to ascertain whether mortality data in the cardiac surgical literature mirror data reported in national databases. METHODS: This was a review of articles with 50 or more subjects reporting single-center mortality data for coronary artery bypass or aortic or mitral valve replacement published in the three major cardiothoracic surgical journals from 1997 through 2000. Mortality data and trends were examined. RESULTS: One hundred sixty-nine articles were found (coronary artery bypass, n = 119; aortic valve replacement, n = 34; mitral valve replacement, n = 16). Articles were predominantly case series (N = 95), with smaller numbers of comparative retrospective studies (n = 34), randomized trials (n = 29), and prospective noncomparative studies (n = 11). The median mortality figures for these studies were 1.5% (interquartile range, 0.3%-2.6%) for coronary artery bypass, 3.4% (interquartile range, 2.0%-5.3%) for aortic valve replacement, and 4.7% (interquartile range, 2.1%-6.9%) for mitral valve replacement. In contrast, the national registry mortality figures were 2.9%, 4.0%, and 6.0%, respectively, in the United States and 2.6%, 4.5% and 6.3%, respectively, in the United Kingdom. Coronary bypass studies with samples smaller than 100 patients reported lower mortality figures (median 0%) than did those with more than 100 patients (1.8%). Exploration with graphical plots suggested a bias toward reporting and publication of studies with below average mortality. CONCLUSIONS: Particularly for coronary artery bypass, published data tend to underrepresent the risk of death as seen in most centers. Outcomes and magnitudes of effects as reported in these research studies may not be replicable to the same degree in most centers. In particular, extreme caution should be taken in extrapolating results from studies with fewer than 100 patients to larger surgical populations.

An economic evaluation of lung transplantation.

OBJECTIVE: This study was undertaken to determine the cost per quality-adjusted life-year gained with lung transplantation relative to medical treatment for end-stage lung disease in the United Kingdom. METHODS: Patients on the transplant waiting list were used to represent medical treatment. Four-year national survival data were extrapolated to 15 years by means of parametric techniques. Quality-adjusted life-years were derived by means of utility scores obtained from a cross-section of patients. Resource consumption and costs were based on local and national sources. Costs and benefits were discounted at an annual rate of 6%. RESULTS: Across a 15-year period lung transplantation yielded mean benefits (relative to medical treatment) of 2.1, 3.3, and 3.6 quality-adjusted life-years for single-lung, double-lung, and heart-lung transplantation, respectively. During the same period the mean cost of medical treatment was estimated at $73,564, compared with $176,640, $180,528, and $178,387 for single-lung, double-lung, and heart-lung transplantation, respectively. The costs per quality-adjusted life-year gained were $48,241 for single-lung, $32,803 for double-lung, and $29,285 for heart-lung transplantation. Sensitivity analysis found the principal determinants of cost-effectiveness to be quality of life and maintenance costs after transplantation. CONCLUSIONS: Lung transplantation results in survival and quality of life gains but remains expensive, with cost-effectiveness limited by substantial mortality and morbidity and high costs. The cost-effectiveness of lung transplantation can be improved with lowered immunosuppression costs and improvements in quality of life after transplantation.

Low incidence and severity of transplant-associated coronary artery disease in heart transplants from live donors.

BACKGROUND: Hearts transplanted from patients undergoing heart-lung transplantation (domino hearts) are unique because they have not been subjected to the deleterious effects of brain-stem death. This study examines the incidence and severity of transplant-associated coronary artery disease in recipients of domino hearts. METHODS: We retrospectively reviewed angiographic and clinical data from 97 patients who survived more than 1 year after domino heart transplantation at our hospital. Duration of follow-up ranged from 1 to 11 years after transplantation. The diagnosis of coronary artery disease was based on angiographic criteria. RESULTS: At 1 year, freedom from angiographic coronary artery disease was 99% (70% confidence interval [CI], 97-100), at 5 years it was 83% (70% CI, 78-89), and at 10 years it was 77% (70% CI, 70-84). Donor age, cystic fibrosis in the donor, organ ischemia time during transplantation, and acute rejection after transplantation did not influence risk for the disease. We found an increased incidence of coronary disease in hearts from male donors compared with those from female donors: freedom from disease at 5 years was 72% (70% CI, 63-81) in men vs 93% (87-99) in women. Thirteen patients experienced coronary artery disease at a median of 3 years after transplantation; 4 patients died but most patients remained asymptomatic with angiographically mild disease at their last follow-up examination. CONCLUSIONS: We found decreased incidence and severity of transplant-associated coronary artery disease in recipients of domino hearts compared with that reported in recipients of cadaveric hearts. This data supports the continued practice of domino heart transplantation and also supports the hypothesis that brain death may contribute to the development of transplant coronary artery disease in recipients of hearts transplanted from cadaveric organ donors.

Long-term results of cardiac transplantation from live donors: the domino heart transplant.

BACKGROUND: Hearts explanted from the recipients of heart-lung transplants provide a unique source of transplants from live donors. This article presents long-term results with this procedure at our center. METHODS: We performed a retrospective chart review of domino transplantations performed in our institution between 1989 and 1998. RESULTS: We analyzed 131 domino transplants (123 orthotopic, 8 heterotopic). Domino hearts were from patients with cystic fibrosis (69%), primary pulmonary hypertension (15%), and other diagnoses (16%). The mean recipient pulmonary vascular resistance (PVR) was 3.1 Wood units, 25% of patients having values >4 Wood units. Thirty-day mortality was 13%. The 1-, 5-, and 10-year graft survival was 75% (70% confidence interval [CI], 65-74), 70% (70% CI, 65-74), and 58% (70% CI, 52-64), respectively. Patients with PVR >4 Wood units had 1-year survival (76%; 70% CI, 69-84) similar to that of patients with PVR of < or =4 units (74%; 70% CI, 69-80). Recipients of hearts from patients with cystic fibrosis survived longer (5-year survival, 76%; 70% CI, 71-82) vs 65% for non-cystic fibrosis hearts (70% CI, 57-74) p = 0.09). One-year survival was decreased after transplantation of hearts from female donors (66%; 70% CI, 60-72)) compared with hearts from male donors (85%; 70% CI, 79-90); p = 0.06). Late deaths caused by coronary artery disease and malignancy were uncommon. CONCLUSION: Although the rate of early mortality after domino transplantation was slightly higher than after cadaveric transplantation, we noted a remarkably low long-term attrition rate in recipients of domino grafts, up to 10 years. In addition, successful transplantation of patients with high PVR supports the hypothesis that heart-lung recipients may provide superior donor hearts for this patient group, many of whom traditional listing criteria would exclude.

Conversion to off-pump coronary bypass without increased morbidity or change in practice.

BACKGROUND: This article examines the feasibility of complete conversion from conventional coronary artery operation to routine off-pump coronary bypass operation. METHODS: Data on our first 285 off-pump procedures using the Octopus system (Medtronic Inc, Minneapolis, MN) represent our learning curve. This is a complete experience in coronary bypass surgery over 16 months. RESULTS: The cohort was nonselected. All patients had at least two-vessel disease. Eight hundred seven grafts were performed (mean, 2.8 per patient) of which 647 grafts (84%) were arterial (mean, 2.3 per patient). One hundred seventy nine patients (63%) underwent total arterial revascularization. Eight patients required cardiopulmonary bypass; all other operations were completed off-pump. Complications were: mortality, 3 patients (1.5%); renal failure, 24 patients (8%); stroke, 2 patients (< 1%); and atrial fibrillation, 60 patients (21%). The morbidity data and frequency of arterial grafting did not differ from that of 355 patients who underwent coronary bypass operations in a preceding 18-month period. CONCLUSIONS: Complete shift from routine use of cardiopulmonary bypass to nonselective off-pump coronary bypass operation is possible with a low conversion rate and without an apparent increase in morbidity or change in technique. Whereas short-term safety and efficacy seem certain, studies of long-term outcome are necessary before the eventual role of off-pump coronary bypass in myocardial revascularization can be defined.

Surgical research revisited: clinical trials in the cardiothoracic surgical literature.

OBJECTIVE: Surgeons have been criticised for not undertaking high-quality research. This study examines the quality of randomised controlled trials (RCTs) in the cardiothoracic surgical literature with a view to revisiting the role of RCTs in surgical research. METHODS: All RCTs published in 1998 and 1999 in three major international cardiothoracic journals were analysed for basic components of trial design and presentation. RESULTS: We found 119 papers presented as RCTs. The median size of treatment arms per RCT was 20 (interquartile range 14-40). Of 20 dimensions of trial quality examined, 12 or more were deficient (not described or performed inadequately) in half of the studies. Key information was frequently missing. Additionally, most trials relied on 'soft' endpoints, using surrogate (72, 61%) rather than clinical, and numerical (102, 86%) rather than categorical outcomes suggesting lack of power to detect clinically relevant differences. Although most trials reported positive results (73, 63%), only in 18 (15%) did authors make recommendations for practice change. CONCLUSIONS: Many RCTs in surgery by virtue of their design, sample size, and insufficient power are incapable of answering the questions researchers seek to address. Surgical trials often may not exclude bias because of lack of blinding and variations in surgical technique and performance. It is arguable that for most study questions in clinical surgery, comparative analysis of large case series and databases will provide more robust evidence.

Surgical strategies for functional tricuspid regurgitation.

Functional or secondary tricuspid regurgitation commonly is found in the setting of left-sided heart disease and, when severe, is associated with substantially poorer functional outcomes and survival if untreated. The traditional view that functional tricuspid regurgitation generally resolves with surgical correction of the primary lesions is no longer held. Data showing late development of severe tricuspid regurgitation in patients with mild regurgitation at time of mitral valve surgery have heralded a new era of aggressive intervention on the tricuspid valve. Tricuspid ring annuloplasty can be performed with minimal incremental morbidity and negligible additional mortality. Therefore, in addition to patients with severe regurgitation, annuloplasty is now also recommended for patients with risk factors for developing late tricuspid insufficiency (typically patients with moderate tricuspid regurgitation or severe annular dilation at time of left-sided cardiac procedures). In this work we review the current indications for tricuspid valve repair in patients undergoing other cardiac surgery operations and also the various options available to the surgeon.

Functional tricuspid regurgitation in mitral valve disease: epidemiology and prognostic implications.

In this review we summarize the data on epidemiology and natural history of functional tricuspid valve regurgitation as it applies to surgery for mitral valve disease. Tricuspid regurgitation in the context of mitral valve disease is frequent and is associated with substantial reduction in survival and quality of life. In many patients, the correction of left-sided cardiac lesions does not lead to resolution of tricuspid regurgitation. Significant tricuspid regurgitation after mitral valve surgery portends a poor prognosis, a course that is often not altered by subsequent surgical therapy. Although a liberal approach to tricuspid annuloplasty is widely practiced, the evidence that this approach alters the natural history of functional tricuspid regurgitation is not yet available, so it is not certain how much of the negative impact of tricuspid regurgitation is causative, rather than confounding, and to what degree we will improve long-term outcomes of mitral valve surgery by liberal tricuspid annuloplasty.

Off-pump implant of the Jarvik 2000 ventricular assist device through median sternotomy.

Implantation of a left ventricular assist device through a median sternotomy usually requires cardiopulmonary bypass. However, the biological response to cardiopulmonary bypass is sometimes deleterious in end-stage heart failure patients, as it may compound pre-existing coagulopathy or multiorgan dysfunction. Therefore, there are potential advantages to avoiding cardiopulmonary bypass during left ventricular assist device placement. We describe a technique for off-pump implantation of the Jarvik 2000 left ventricular assist device (Jarvik Heart Inc, New York, NY) through a median sternotomy.

Epidemiology of stroke after cardiac surgery in the current era.

OBJECTIVE: Previous studies of the epidemiology of stroke in patients undergoing cardiac surgery have been based primarily on patients having coronary bypass surgery and therefore have limited applicability to the more heterogenous populations seen in the current era. We examine the epidemiology of stroke after cardiac surgery in a contemporary surgical population. METHODS: Retrospective analysis was conducted of a prospective database of 5085 adults (coronary bypass 2401, isolated valve 1003, valve/coronary bypass 546, thoracic aorta 517, transplant/assist device 179, adult congenital 124, other 315) who had cardiac surgery at a single institution over a 6-year period (1998-2004). RESULTS: Stroke occurred in 134 (2.6%) patients. Incidence varied according to procedure (coronary bypass 1.7%, isolated valve 1.8%, valve/coronary bypass 4.4%, and ascending aorta 4.6%). Patients who had a stroke had a higher perioperative mortality rate than that of patients who did not (32.8% vs 4.9%; P < .0001) and a longer period of hospitalization (median 30 days vs 7 days; P < .0001). Multivariate logistic analysis identified 10 preoperative predictors of stroke: gender, age, aortic surgery, previous stroke, critical preoperative state, poor ventricular function, diabetes, peripheral vascular disease, unstable angina, and pulmonary hypertension. A logistic model was developed on the basis of these risk factors to predict the likelihood of stroke. CONCLUSIONS: We have demonstrated a relatively low incidence of stroke in a diverse contemporary cardiac surgical cohort. By enabling preoperative identification of patients at risk, our logistic model has the potential to improve preoperative patient counseling and selection and could help to define high-risk cohorts for research into stroke prevention.

Large annuloplasty rings facilitate mitral valve repair in Barlow's disease.

BACKGROUND: Excess leaflet tissue in Barlow's disease predisposes patients to left ventricular outflow tract obstruction and residual mitral regurgitation after mitral valve repair as a result of systolic anterior motion of the anterior mitral leaflet. In addition to conventional repair techniques such as sliding plasty and leaflet shortening, our approach in Barlow's disease has included the use of large remodeling annuloplasty rings (up to size 40 mm). We report our experience with the use of large rings in Barlow's disease. METHODS: From January 2002 to December 2005, 67 patients with Barlow's disease (46 men and 21 women; median age, 55 years; range, 22 to 85 years), mean ejection fraction 0.55 +/- 0.08, and grade 3+ or greater mitral regurgitation underwent mitral valve repair. All had Carpentier type II leaflet dysfunction, with anterior (n = 2), posterior (n = 41), or bileaflet (n = 24) prolapse. Predominant reconstructive techniques were posterior leaflet sliding plasty/plication (n = 65), anterior leaflet triangular resection (n = 16), and chordal transfer (n = 25). Concomitant procedures included coronary artery bypass grafting surgery (n = 8), tricuspid valve repair (n = 20), aortic valve replacement (n = 3), and CryoMaze (n = 22). RESULTS: Mitral valve repair was successfully completed in all patients. Annuloplasty ring size was 36 mm (n = 17), 38 mm (n = 22), and 40 mm (n = 28). Predischarge transthoracic echocardiography showed absence of systolic anterior motion (n = 67), no or trace mitral regurgitation (n = 62), and mild mitral regurgitation (n = 5). There was no operative mortality. CONCLUSIONS: Mitral valve repair can be predictably performed in Barlow's disease with excellent early outcomes. Large annuloplasty rings help minimize the risk of systolic anterior motion and are an important adjunct to established repair techniques in this patient cohort with large annular size and excess leaflet tissue.

Long-term outcomes of tricuspid valve replacement in the current era.

BACKGROUND: Regardless of the indication, tricuspid valve replacement (TVR) has historically been associated with high mortality and morbidity. We report the results of our experience in a high-risk patient population with an emphasis on operative mortality, long-term survival, and valve related events according to the type of prosthesis. METHODS: Between 1985 and 1999 TVR was performed in 81 patients (isolated n = 25, combined with valve surgery n = 44, combined with CABG or other n = 12). The mean age was 61 years old (range 19-83 years old). Risk factors included New York Heart Association functional class III/IV (n = 73, 90%), reoperation (n = 58, 72%), urgent/emergent indication (n = 62, 76%), and hepatic dysfunction (n = 13, 16%). Mean pulmonary artery pressure was 34 mmHg. Etiology of tricuspid regurgitation was classified as functional (n = 18, 22%) or organic (n = 52, 64%), or failed previous tricuspid valve surgery (n = 11, 14%). RESULTS: Tricuspid valve replacement was performed with either a bioprosthetic (n = 34, 42%) or mechanical valve (n = 47, 58%). The overall operative mortality was 22% (n = 18). Risk factors for mortality included urgent/emergent status, age greater than 50 years old, functional etiology, and elevated pulmonary artery pressure. Of the 60 survivors, 26 (43%) died during follow up. After univariate analysis, organic etiology was the only predictor of late death (p = 0.01). Kaplan-Meier survival at 2.5, 5, and 10 years was 80%, 60%, and 45% for bioprosthetic, and 84%, 69%, and 59% for mechanical valves, respectively. CONCLUSIONS: Patients requiring TVR are typically high-risk with a high-percentage of reoperations, concomitant cardiac procedures, and end-stage functional class. Operative and overall mortality remains high. Heart failure was the predominant cause of early and late deaths, emphasizing importance of timely referral before the development of end-stage cardiac impairment.