Joseph J. DeRose

Two-Year Outcomes of Surgical Treatment of Severe Ischemic Mitral Regurgitation

BACKGROUND In a trial comparing coronary-artery bypass grafting (CABG) alone with CABG plus mitral-valve repair in patients with moderate ischemic mitral regurgitation, we found no significant difference in the left ventricular end-systolic volume index (LVESVI) or survival after 1 year. Concomitant mitral-valve repair was associated with a reduced prevalence of moderate or severe mitral regurgitation, but patients had more adverse events. We now report 2-year outcomes. METHODS We randomly assigned 301 patients to undergo either CABG alone or the combined procedure. Patients were followed for 2 years for clinical and echocardiographic outcomes. RESULTS At 2 years, the mean (±SD) LVESVI was 41.2±20.0 ml per square meter of body-surface area in the CABG-alone group and 43.2±20.6 ml per square meter in the combined-procedure group (mean improvement over baseline, -14.1 ml per square meter and -14.6 ml per square meter, respectively). The rate of death was 10.6% in the CABG-alone group and 10.0% in the combined-procedure group (hazard ratio in the combined-procedure group, 0.90; 95% confidence interval, 0.45 to 1.83; P=0.78). There was no significant between-group difference in the rank-based assessment of the LVESVI (including death) at 2 years (z score, 0.38; P=0.71). The 2-year rate of moderate or severe residual mitral regurgitation was higher in the CABG-alone group than in the combined-procedure group (32.3% vs. 11.2%, P<0.001). Overall rates of hospital readmission and serious adverse events were similar in the two groups, but neurologic events and supraventricular arrhythmias remained more frequent in the combined-procedure group. CONCLUSIONS In patients with moderate ischemic mitral regurgitation undergoing CABG, the addition of mitral-valve repair did not lead to significant differences in left ventricular reverse remodeling at 2 years. Mitral-valve repair provided a more durable correction of mitral regurgitation but did not significantly improve survival or reduce overall adverse events or readmissions and was associated with an early hazard of increased neurologic events and supraventricular arrhythmias. (Funded by the National Institutes of Health and Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT00806988.).

Robotically assisted left ventricular epicardial lead implantation for biventricular pacing

OBJECTIVES Ventricular resynchronization might be achieved in a minimally invasive fashion using a robotically assisted, direct left ventricular (LV) epicardial approach. BACKGROUND Approximately 10% of patients undergoing biventricular pacemaker insertion have a failure of coronary sinus (CS) cannulation. Rescue therapy for these patients currently is limited to standard open surgical techniques. METHODS Ten patients with congestive heart failure (New York Heart Association class 3.4 +/- 0.5) and a widened QRS complex (184 +/- 31 ms) underwent robotic LV lead placement after failed CS cannulation. Mean patient age was 71 +/- 12 years, LV ejection fraction (EF) was 12 +/- 6%, and LV end-diastolic diameter was 7.1 +/- 1.3 cm. Three patients had previous cardiac surgery, and five patients had a prior device implanted. RESULTS Nineteen epicardial leads were successfully placed on the posterobasal surface of the LV. Intraoperative lead threshold was 1.0 +/- 0.5 V at 0.5 ms, R-wave was 18.6 +/- 8.6 mV, and impedance was 1,143 +/- 261 ohms at 0.5 V. Complications included an intraoperative LV injury and a postoperative pneumonia. Improvements in exercise tolerance (8 of 10 patients), EF (19 +/- 13%, p = 0.04), and QRS duration (152 +/- 21 ms, p = 0.006) have been noted at three to six months follow-up. Lead thresholds have remained unchanged (2.1 +/- 1.4 V at 0.5 ms, p = NS), and a significant drop in impedance (310 +/- 59 ohms, p < 0.001) has been measured. CONCLUSIONS Robotic LV lead placement is an effective and novel technique which can be used for ventricular resynchronization therapy in patients with no other minimally invasive options for biventricular pacing.

Implantable Left Ventricular Assist Devices Provide an Excellent Outpatient Bridge to Transplantation and Recovery

OBJECTIVES Our recent experience with outpatient left ventricular assist device (LVAD) support is presented to demonstrate the possibilities and limitations of long-term outpatient mechanical circulatory assistance. BACKGROUND The experience with inpatient LVAD support as a bridge to transplantation has proved the efficacy of such therapy in improving circulatory hemodynamic status, restoring normal end-organ function and facilitating patient rehabilitation. With miniaturization of the power supplies and controllers, such mechanical circulatory support can now be accomplished in an outpatient setting. METHODS Between March 1993 and February 1997, 32 patients (26 male, 6 female, mean [+/-SEM] age 49 +/- 15 years) underwent implantation of the ThermoCardiosystems (TCI) Heartmate vented electric (VE) LVAD. The VE LVAD is powered by batteries worn on shoulder holsters and is operated by a belt-mounted system controller, allowing unrestricted patient ambulation and hospital discharge. RESULTS Mean duration of support was 122 +/- 26 days (range 3 to 605), with a survival rate to transplantation or explantation of 78%. Nineteen patients were discharged from the hospital on mean postoperative day 41 +/- 4 (range 17 to 68), for an outpatient support time of 108 +/- 30 days (range 2 to 466). Four patients underwent early transplantation and could not participate in the discharge program, and three patients currently await discharge. The complication rate was not statistically different from that encountered in our previous 52 patients with a pneumatic LVAD. CONCLUSIONS Outpatient LVAD support is safe and provides improved quality of life for patients awaiting transplantation. Wearable and totally implantable LVADs should be studied as permanent treatment options for patients who are not candidates for heart transplantation.

European system for cardiac operative risk evaluation predicts long-term survival in patients with coronary artery bypass grafting

OBJECTIVE To evaluate the accuracy of predicting long-term mortality in patients with coronary artery bypass grafting (CABG) by using the European system for cardiac operative risk evaluation (EuroSCORE). METHODS Medical records of patients with CABG (n=3760) between January 1992 and March 2002 were retrospectively reviewed and their predicted surgical risk was calculated according to the standard (study A) and logistic (study B) EuroSCORE. In study A the patients were divided into six groups: 0-2 (n=610), 3-5 (n=1479), 6-8 (n=1099), 9-11 (n=452), 12-14 (n=103) and >14 (n=17). In study B the patients were divided into seven groups: 0.00-2.00 (n=447), 2.01-5.00 (n=1190), 5.01-10.00 (n=890), 10.01-20.00 (n=686), 20.01-30.00 (n=234), 30.01-60.00 (n=254) and >60.00 (n=59). Long-term survival was obtained by the National Death Index and Kaplan-Meier curves were constructed and compared employing the log-rank test. Multivariate Cox regression analysis was performed in order to control for pre, intra and postoperative factors and adjusted hazard ratios were calculated for standard and logistic EuroSCORE groups. The receiver operating characteristic (ROC) curves were plotted to assess the discrimination ability of the EuroSCORE. RESULTS In study A there were differences among the six groups in 30-day mortality (0.7%, 1.0%, 3.1%, 4.6%, 13.6% and 23.5%; P<0.001), in major complications (8.5%, 10.4%, 16.2%, 20.4%, 31.1% and 35.3%; P<0.001) as well as in actuarial long-term survival (86.2%, 79.6%, 53.6%, 37.9%, 24.9% and 0% from EuroSCORE 0-2 to >14; P<0.001). In study B there were differences among the seven groups in 30-day mortality (0.9%, 1.1%, 1.2%, 3.6%, 3.4%, 8.7% and 15.3%; P<0.001), major complications (8.5%, 10.1%, 12.1%, 18.4%, 16.2%, 26.0% and 30.5%; P<0.001) as well as in actuarial long-term survival (89.5%, 79.9%, 66.9%, 51.0%, 40.3%, 38.4% and 13.7% from EuroSCORE 0.00-2.00 to >60.00; P<0.001). Multivariate Cox regression analysis confirmed that EuroSCORE (standard or logistic) was a statistically significant predictor for long-term mortality, while the area under the ROC curve was 0.72 for either standard or logistic EuroSCORE. CONCLUSION The predicted surgical risk in CABG patients as calculated by standard or logistic EuroSCORE is a strong predictor for long-term survival in addition to predicting operative survival for which it was originally designed.

Improved survival rates support left ventricular assist device implantation early after myocardial infarction

OBJECTIVES Implantation of left ventricular assist devices (LVADs) early after acute myocardial infarction (MI) has traditionally been thought to be associated with high mortality rates due to technical limitations and severe end-organ dysfunction. At some experienced centers, doctors have refrained from earlier operation after MI to allow for a period of hemodynamic and end-organ stabilization. METHODS We retrospectively investigated the effect of preoperative MI on the survival rates of 25 patients who received a Thermocardiosystems Incorporated LVAD either <2 weeks (Early) (n = 15) or >2 weeks (Late) (n = 10) after MI. Outcome variables included perioperative right ventricular assistance (and right-sided circulatory failure), hemodynamic indexes, percent transplanted or explanted, and mortality. RESULTS No statistically significant differences were demonstrated between demographic, perioperative or hemodynamic variables between the Early and Late groups. Patients in the Early group demonstrated a lower rate of perioperative mechanical right ventricular assistance, but had a higher rate of perioperative inhaled nitric oxide use. In addition, 67% of patients in the Early group survived to transplantation and 7% to explantation, findings comparable to those in the Late group (60% and 0% respectively). CONCLUSIONS This clinical experience suggests that patients may have comparable outcomes whether implanted early or late after acute MI. These data therefore support the early identification and timely application of this modality in post-MI LVAD candidates, as this strategy may also reveal a subgroup of patients for whom post-MI temporary LVAD insertion may allow for full ventricular recovery.

Improved Results for Postcardiotomy Cardiogenic Shock With the Use of Implantable Left Ventricular Assist Devices

BACKGROUND Over the past decade, the use of mechanical circulatory support in patients with postcardiotomy cardiogenic shock has resulted in hospital discharge rates of 25% to 40%. In an attempt to improve patient survival, we initiated a program of early insertion of an implantable Thermocardiosystems Incorporated Heartmate left ventricular assist device in patients who have circulatory failure after having undergone high-risk cardiac operations. METHODS Between April 1993 and February 1997, 12 patients underwent insertion of an implantable left ventricular assist device for postcardiotomy cardiogenic shock after coronary artery bypass grafting. Indications for insertion included postoperative cardiogenic shock (7 patients), postoperative cardiac arrest (3 patients), and failure to wean from cardiopulmonary bypass (2 patients). RESULTS The median time to device insertion was 3.5 days. The mean duration of left ventricular assist device support was 103 +/- 19 days (range, 2 to 225 days). Nine of 11 patients (82%) survived to undergo either transplantation (8 patients) or explantation (1 patient), with successful hospital discharge of all 9 patients. The major complication was device-related infection (42%). A single thromboembolism occurred in a patient with an infection. CONCLUSIONS Long-term outcome after postcardiotomy cardiogenic shock is improved substantially with the use of an implantable left ventricular assist device early in the postoperative course. Access to such a device is an important consideration before undertaking a high-risk cardiac operation, and early implantation of the device is a critical factor in ensuring long-term survival.

Robotically assisted left ventricular epicardial lead implantation for biventricular pacing: the posterior approach.

Patients with congestive heart failure and altered interventricular conduction enjoy improvements in quality of life and ventricular function after successful resynchronization therapy with biventricular pacing. Technical limitations owing to individual coronary sinus and coronary venous anatomy result in a 10% to 15% failure rate of left ventricular (LV) lead placement through percutaneous approaches. To provide a minimally invasive option for these patients with LV lead failures, we developed a technique of endoscopic, epicardial LV lead implantation with the use of the da Vinci robotic system. The surgical approach targets the posterolateral wall through a novel posterior approach.

Inhaled nitric oxide improves hemodynamics in patients with acute pulmonary hypertension after high-risk cardiac surgery.

Severe pulmonary hypertension and right-sided circulatory failure (RSCF) represent an increasing cause of morbidity and mortality in patients undergoing high-risk cardiac surgery. Increased pulmonary vascular resistance in the setting of cardiopulmonary bypass (CPB) may further lead to decreased blood flow across the pulmonary vascular bed; thereby decreasing left ventricular filling and cardiac output. Current management techniques for RSCF include both nonspecific vasodilator and inotropic agents (often limited by systemic hypotension) and the placement of right ventricular assist devices (associated with increased perioperative morbidity). Inhaled nitric oxide (NOi) represents a novel, specific pulmonary vasodilator that has been proven efficacious in these clinical settings. We evaluated 34 patients in 38 operations who underwent cardiac surgery at Columbia Presbyterian Medical Center, and who received NOi (20 ppm) through a modified ventilatory circuit for hemodynamically significant elevations in pulmonary vascular resistance. Nine patients underwent cardiac transplantation, three patients bilateral lung transplantation, 16 patients left ventricular assist device placement and 10 patients routine cardiac surgery. Patients receiving NOi exhibited substantial reductions in mean pulmonary artery pressure (mPAP) (34.6 ± 2.0 to 26.0 ± 1.7 mmHg, p < 0.0001), with improvements in systemic hemodynamics, mean arterial pressure (68 ± 3.1 to 75.9 ± 2.0 mmHg, p = 0.006). In five cases, patients could not be weaned from CPB until NOi was administered. Patients were maintained on NOi from 6 to 240 h postoperatively (median duration 36 h). Inhaled NO induces substantial reductions in mPAP and increases in both cardiac index and systemic blood pressure in patients displaying elevated pulmonary hemodynamics after high-risk cardiac surgery. NO is, therefore, a useful adjunct in these patients in whom acute pulmonary hypertension threatens right ventricular function and hemodynamic stability.

Retinoic acid suppresses intimal hyperplasia and prevents vessel remodeling following arterial injury

Vitamin A and its derivatives (retinoids) are capable of inhibiting vascular smooth muscle cell proliferation in vitro. The present study examines the effect of two retinoids, all-trans retinoic acid and 13-cis retinoic acid, on intimal hyperplasia following arterial injury. After receiving varying doses of all-trans retinoic acid or 13-cis retinoic acid, 78 male Sprague-Dawley rats underwent standard balloon catheter denudation of the left common carotid artery. Morphometric analysis and immunohistochemistry for proliferating cell nuclear antigen was performed at early and late time points. Intimal/medial ratios were reduced in a dose-dependent fashion for animals treated with all-trans retinoic acid (P = 0.001) and 13-cis retinoic acid (P = 0.004). Proliferating cell nuclear antigen labeling indices were reduced after treatment with all-trans retinoic acid and 13-cis retinoic acid at early time points post-injury. At a dose of 10 mg/kg, both all-trans retinoic acid and 13-cis retinoic acid inhibited vessel remodeling as measured by increases in luminal diameter (P < 0.05) and external elastic lamina (P < 0.05). Retinoids are an attractive clinical option for the treatment of restenosis following angioplasty and arterial surgery.

Totally endoscopic robotic thymectomy for myasthenia gravis

The current recommendations for treating myasthenia gravis include surgical thymectomy for patients between puberty and 60 years of age. This is a report of a new method for surgical thymectomy using the robotic da Vinci surgical system for a totally endoscopic approach. This new procedure combines the potential advantages of minimally invasive methods with the efficacy of open procedures.