Does elective or emergent operative status influence outcomes in patients undergoing implantation of left ventricular assist devices?

BACKGROUND: Acuity models to predict survival after left ventricular assist device (LVAD) implantation do not include operative status as one of the calculated variables. The effect of elective versus emergent LVAD implantation on outcomes has not been examined. METHODS: Patients were stratified into 2 groups based on operative status (elective versus emergent). Variables were compared to determine whether there were differences in outcomes between elective versus emergent LVAD recipients RESULTS: Of the 130 patients, 59 underwent an elective procedure, whereas 71 had their LVAD implanted as an urgent/emergent operation. Patients in the urgent/emergent cohort had significantly worse preoperative hepatic and renal function and higher central venous pressures. Survival rates at 30 days, 6 months, 1 year, and 2 years were analogous for both cohorts. Patients in the emergent cohort had a higher incidence of postoperative right ventricular failure, with the requirement for short-term right ventricular support in 9.9% versus 1.7% (P = 0.054). The incidence of other LVAD-related complications, were similar in both groups. Emergency status did not predict postoperative mortality in univariate analysis. CONCLUSIONS: Although patients who underwent emergent LVAD implantations had worse preoperative renal and liver function and a higher incidence of postoperative right ventricular failure, they exhibited similar midterm survival and a similar incidence of other postoperative complications.

Is resternotomy a risk for continuous-flow left ventricular assist device outcomes?

BACKGROUND: The number of patients undergoing resternotomy continues to rise. Although catastrophic hemorrhage remains a dreaded complication, most published data suggest that sternal reentrance is safe, with negligible postoperative morbidity and mortality. A significant proportion of left ventricular assist device (LVAD) implantations are reoperative cardiac procedures. The aim of our study was to compare outcomes between first time sternotomy and resternotomy patients receiving continuous-flow LVADs, as a bridge to transplantation or destination therapy. METHODS AND MATERIALS: From March 2006 through February 2012, 100 patients underwent implantation of a HeartMate II or HeartWare LVAD at our institution. Patients were stratified into two groups, primary sternotomy and resternotomy. Variables were compared using two-sided t-tests, chi-square tests, Cox proportional hazards models, and log-rank tests to determine whether there was a difference between the two groups and if resternotomy was a significant independent predictor of outcome. RESULTS: We identified 29 patients (29%) who had resternotomy and 71 patients (71%) who had first time sternotomy. The resternotomy group was significantly older (56 years vs. 51 years, p = 0.05), was more likely to have ischemic cardiomyopathy (ICM) (69% vs. 30%, p < 0.001), chronic obstructive pulmonary disease (COPD) (31% vs. 14%, p = 0.05) and had longer cardiopulmonary bypass times (135 min vs. 100 min, p = 0.011). Survival rates at 30 days (93.1% vs. 95.8%, p = 0.564), 180 days (82.8% vs. 93%, p = 0.131), and 360 days (82.8% vs. 88.7%, p = 0.398) were similar for the resternotomy and primary sternotomy groups, respectively. Postoperative complications were also comparable, except for re-exploration for bleeding which was higher for the resternotomy group (17.2% vs. 4.2%, p = 0.029), although blood transfusion requirements were not significantly different (1.4 units vs. 1.2 units, p = 0.815). Left and right heart catheterization measurements and echocardiographic (ECHO) findings after 1 and 6 months of LVAD therapy were similar between the two groups. CONCLUSIONS: Survival at 30, 180, and 360 days after LVAD implantation is similar between the resternotomy and primary sternotomy group. No major differences in complications or hemodynamic measurements were observed. Although a limited observational study, our findings agree with previously published resternotomy outcomes.

Long-term right ventricular assist device support for congenitally corrected transposition of the great arteries.

With congenitally corrected transposition of the great arteries, the right ventricle (RV) supports the systemic circulation. These patients have an increased risk of developing heart failure. Implantation of a ventricular assist device may be the only therapeutic option for patients who are not transplantation candidates. The technical aspects of implanting a mechanical device into the RV have not been well described, however. We describe our experience with one such case and describe our operative strategy in obtaining optimal placement of the inflow cannula.

Sleep and daytime sleepiness of patients with left ventricular assist devices: a longitudinal pilot study.

CONTEXT: No empirical longitudinal data on sleep and daytime sleepiness patterns in patients with an implantable left ventricular assist device (LVAD) exist. OBJECTIVE: (1) To describe the sleep patterns (sleep onset latency, sleep efficiency, sleep fragmentation index, total sleep time, and wake after sleep onset), sleep quality, and daytime sleepiness variables and (2) to determine the change in the pattern of these variables before and up to 6 months after LVAD implantation. DESIGN: A longitudinal descriptive repeated-measures design was used. Patients wore wrist actigraphs (AW64 Actiwatch), which objectively measured sleep, for 3 consecutive days and nights before LVAD implant and at the first and second week and first, third, and sixth month after implantation. During these periods, patients also completed questionnaires on sleep quality and daytime sleepiness. Patients-Twelve of 15 patients completed the 6-month data. Data were analyzed by using descriptive statistics and repeated-measures analysis of variance. RESULTS: We found long sleep onset latencies and low sleep efficiency across time periods. High sleep fragmentation index was noted at baseline and 1 week after LVAD. Short total sleep times, long wake-after-sleep-onset durations, and poor sleep quality were evident at baseline and persisted up to 6 months after LVAD implantation. Low alertness level, a manifestation of sleepiness, was common during late morning to early evening hours. However, only sleep efficiency and wake after sleep onset showed significant changes in pattern (P < .05). CONCLUSION: Sleep disturbance and daytime sleepiness may be prevalent before and up to 6 months after LVAD implantation, warranting further investigation.

Video-assisted thorascopic removal of migratory acupuncture needle causing pneumothorax.

We report the case of a 25-year-old African-American man presenting to the Henry Ford Hospital emergency department with acute dyspnea secondary to a pneumothorax resulting from a migratory acupuncture needle. The patient received acupuncture treatment approximately 5 years prior to this presentation for treatment of posttraumatic chronic right shoulder pain. Chest radiography revealed retained needles in his right shoulder girdle and a needle overlying the thoracic cage with an attendant pneumothorax. Catheter aspiration for simple pneumothorax provided immediate symptomatic relief. Video-assisted thoracoscopy was then used to remove the migratory acupuncture needle from the chest wall. The patient recovered without complication and was discharged to home.

Outcomes of patients with right ventricular failure on milrinone after left ventricular assist device implantation.

Previous studies have grouped together both patients requiring right ventricular assist devices (RVADs) with patients requiring prolonged milrinone therapy after left ventricular assist device (LVAD) implantation. We retrospectively identified 149 patients receiving LVADs and 18 (12.1%) of which developed right ventricular (RV) failure. We then separated these patients into those requiring RVADs versus prolonged milrinone therapy. This included 10 patients who were treated with prolonged milrinone and eight patients who underwent RVAD placement. Overall, the RV failure group had worse survival compared with the non-RV failure cohort (p = 0.038). However, this was only for the subgroup of patients who required RVADs, who had a 1, 6, 12, and 24 month survival of 62.5%, 37.5%, 37.5%, and 37.5%, respectively, versus 96.8%, 92.1%, 86.7%, and 84.4% for patients without RV failure (p < 0.001). Patients treated with prolonged milrinone therapy for RV failure had similar survivals compared with patients without RV failure. In the RV failure group, age, preoperative renal failure, and previous cardiac surgery were predictors of the need for prolonged postoperative milrinone. As LVADs become a more widely used therapy for patients with refractory, end-stage heart failure, it will be important to reduce the incidence of RV failure, as it yields significant morbidity and increases cost.

Lessons learned from 150 continuous-flow left ventricular assist devices: a single institutional 7 year experience.

Continuous-flow (CF) left ventricular assist devices (LVADs) have become the standard of care for patients with advanced heart failure refractory to optimal medical therapy. The goal of this study was to review our 7 year single institutional experience with CF LVADs. Mean age was 50.4 + 12.5 (17-69) years for bridge-to-transplantation (BTT) patients and 57.6 + 10.4 (31-81) years for destination therapy (DT) patients (p < 0.001). Overall, 38 patients (26%) were female and 58 (41%) were African American. Etiology of heart failure was ischemic in 54 patients (37%) and nonischemic in 93 patients (63%). Overall survival at 30 days, 6 months, 12 months, and 2 years was 93%, 89%, 84%, and 81%, respectively. Gastrointestinal bleeding (GIB) was the most common complication (24%), followed by stroke (18%), right ventricular (RV) failure (18%), ventilator-dependent respiratory failure (10%), reoperation for bleeding (10%), and driveline infection (9%). These data demonstrate excellent survival with low mortality for both BTT and DT patients on long-term LVAD support. However, for LVAD therapy to become the gold standard for long-term treatment of end-stage heart failure and a plausible alternative to heart transplantation, we need to continue to improve the incidence of frequent postoperative complications, such as RV failure, driveline infections, strokes, and GIB.

Reduction in driveline infection rates: Results from the HeartMate II Multicenter Driveline Silicone Skin Interface (SSI) Registry.

BACKGROUND: During left ventricular assist device implantation, a surgical tunneling technique to keep the entire driveline (DL) velour portion in the subcutaneous tunnel, resulting in a silicone-skin interface (SSI) at the exit site, has been adopted by many centers. To assess long-term freedom from DL infection associated with this technique, a multicenter SSI registry was initiated. It was hypothesized that the modified tunneling technique is associated with at least 50% reduction in DL infection at 1 year post-implant compared with the velour-to-skin method used in the HeartMate II (HMII) Destination Therapy (DT) trial. METHODS: SSI is a retrospective and prospective registry of patients who have received the HMII device. Results are reported from the retrospective cohort, which consists of 200 patients who were implanted during the period 2009-2012 with the SSI tunneling method and on HMII support for at least 10 months at the time of enrollment. The prevalence and incidence of DL infection after left ventricular assist device implantation in the SSI retrospective cohort were determined and compared with a control group of 201 patients also on HMII support for at least 10 months from the HMII DT clinical trial who were implanted during the period 2007-2009 using the traditional method in which a small section of the velour portion of the DL was externalized. RESULTS: The 1-year and 2-year prevalence rates of DL infection were 9% and 19% in the SSI patient group compared with 23% and 35% in the control group (hazard ratio 0.49, 95% confidence interval 0.33-0.73, p < 0.001). The event-per-patient year was 0.11 and 0.22 for the SSI and control groups, respectively (p < 0.001). Based on a multivariate analysis, age and DL exit side were the only independent variables associated with DL infection. Effects of management changes over the eras were not studied and could have contributed to the findings. CONCLUSIONS: These results suggest that leaving the entire DL velour portion below the skin is associated with 50% reduction in DL infection compared with results from the HMII DT trial.

Spontaneous closure of a perforation-induced coronary artery pseudoaneurysm.

We describe an unusual case of a coronary perforation presenting as a large pseudoaneurysm. An elderly woman who had undergone percutaneous coronary intervention several months earlier presented with shortness of breath. Cardiac catheterization revealed a large pseudoaneurysm arising from the proximal circumflex artery. At follow-up angiography a few days later, the pseudoaneurysm had spontaneously closed. In the discussion, we describe the incidence and treatment of this rare complication.

Sex-specific outcomes in patients receiving continuous-flow left ventricular devices as a bridge to transplantation or destination therapy.

Reports on sex-related outcomes in left ventricular assist device (LVAD) patients are conflicting. In addition, females have been underrepresented in most multicenter randomized controlled trials for mechanical circulatory support (MCS). The objective of our study was to analyze our experience implanting 130 continuous-flow LVADs and to determine the impact of sex on survival. We identified 130 patients who underwent implantation of a continuous-flow LVAD at our institution. Patients were stratified into two groups based on sex. Variables were compared using two-sided t-tests, χ(2) tests, Cox proportional hazards models, and log-rank tests to determine whether there was a difference between the two groups and if sex was a significant independent predictor of outcome. Of the 130 patients, 35 were females and 95 were males. Female patients had worse pre-LVAD cardiac output and cardiac index and were more likely to be on MCS at the time of implantation. Male patients had worse renal function. Survival was analogous for both cohorts with 30 day, 6 month, 1 year, and 2 year survivals of 97%, 90.8%, 90.8%, and 84.3%, respectively, for female patients versus 94.7%, 87.9%, 78.4%, and 72.8%, respectively, for male patients. The incidence of other LVAD-related complications was also similar in both groups. Gender did not predict postoperative mortality on univariate analysis. Contrary to most published reports, female and male LVAD patients have similar postoperative and midterm survival, length of hospital stay, readmission rates, and postoperative complications. It appears that females have gained more benefit from newer generation devices compared to males.

Factors determining post-operative readmissions after left ventricular assist device implantation.

BACKGROUND: In the current era of extensive healthcare reform, there has been a heightened focus on the frequency and cause for readmissions within 30 days of discharge given that readmissions are not reimbursed by most providers. The aim of our study was to determine the frequency, etiology and patterns of 30-day readmissions among recipients of continuous-flow left ventricular assist devices (LVADs) at our institution as well to determine whether there were any significant predictors of readmission. METHODS: From March 2006 through June 2013, 150 patients underwent implantation of a continuous-flow LVAD at our institution. Patients were stratified into two groups based on their 30-day readmission status. A total of 12 patients died before discharge and were excluded from our analysis. Causes for 30-day readmissions and duration of hospital stay for the readmissions were recorded. Numerous pre-operative variables and post-operative complications were compared using 2-sided t-tests and chi-square tests between patients who were and were not readmitted within 30 days of their discharge after their LVAD implant. RESULTS: The 30-day readmission rate was 26.1% (36 of 138), with approximately 70% of post-operative readmissions occurring within 10 days of the patient's initial hospital discharge. Recurrent heart failure (12 of 36, 33.3%) and gastrointestinal bleeding (8 of 36, 22.2%) were the most common causes for 30-day readmission. The median length of stay (LOS) for readmission was 11.7 days. Thirty-day readmission did not affect short- or long-term survival. On univariate analysis, post-operative gastrointestinal bleeding (GIB) was a significant risk factor for 30-day readmissions (HR 1.4, 95% CI 0.19 to 0.99, p = 0.05), and overall length of stay was a significant factor in reducing 30-day readmission rates (HR 0.91, 95% CI 0.85 to 0.99, p = 0.02). CONCLUSIONS: Our experience indicates that 30-day readmission rates after LVAD implantation remain relatively high, with most occurring within 10 days of discharge. Recurrent heart failure and GIB were the most common causes of post-operative rehospitalization. In addition, GIB during the index hospitalization was a significant predictor of 30-day readmission.

Stroke while on long-term left ventricular assist device support: incidence, outcome, and predictors.

Development of stroke while on left ventricular assist device (LVAD) support can be a source of significant morbidity and mortality. From March 2006 through November 2011, one hundred patients with chronic heart failure underwent implantation of a HeartMate II (HM II) LVAD (Thoratec Corp.) as a bridge to transplant (BTT; n = 65) or destination therapy (DT; n = 35). Records were reviewed to determine the prevalence and type of postimplant stroke, anatomic cerebral location of strokes, and associated morbidity and mortality. Cox multivariate logistic regression analysis was conducted to identify independent predictors of postoperative stroke. Strokes occurred in 12 patients (12.0%): four embolic and eight hemorrhagic. Median duration of support at the time of stroke was 281.0 days for embolic strokes and 380.5 days for hemorrhagic strokes (p = 0.028). Stroke patients had a significantly higher incidence of diabetes (66.7% vs. 40.9%; p = 0.024), history of preimplant stroke (16.7% vs. 4.5%; p = 0.046), and aortic cross-clamping with cardioplegic arrest during their LVAD implant (50.0% vs. 20.2%; p = 0.034) compared with patients without postoperative strokes. Mean international normalized ratio (INR) at the time of stroke was subtherapeutic in all four patients with embolic strokes (mean: 1.5 ± 0.1 IU; range 1.3-1.6 IU) and supratherapeutic in four of eight patients with hemorrhagic strokes (mean: 3.2 ± 2.2 IU, range: 1.4-7.0 IU; p = 0.024). There was a 25.0% 30 day mortality after stroke. Diabetes (odds ratio [OR] 6.36; p = 0.029), aortic cross-clamping with cardioplegic arrest (OR 4.75; p = 0.025), duration of LVAD support (OR 1.00; p = 0.008), and INR (OR 4.42; p = 0.020) were independent predictors of stroke in multivariate analysis with a trend toward significance for history of stroke (OR 6.25; p = 0.075). Stroke represented an important source of morbidity and mortality for patients on HM II LVAD support. As long-term device therapy continues to gain popularity for both BTT and DT, a better understanding of the predictors of stroke, more strict control of postoperative anticoagulation, and the establishment of a risk stratification model may aid in minimizing its occurrence.

Relationship of tricuspid repair at the time of left ventricular assist device implantation and survival.

PURPOSE: Tricuspid regurgitation contributes to right ventricular failure (RVF) and is associated with worse clinical outcomes in patients undergoing left ventricular assist device (LVAD) treatment. However, whether tricuspid valve repair (TVR) at the time of LVAD implantation improves outcomes is not clear. METHODS: We identified all patients undergoing initial implantation of a long-term continuous-flow LVAD at our institution from March 2006 to August 2011. We assessed the impact of TVR on survival and incidence of RVF using Kaplan-Meier curves and proportional hazards regression adjusted for age, gender, baseline tricuspid regurgitation, RV function, MELD score, albumin, and indication (bridge vs. destination). RESULTS: A total of 101 patients were included in the analysis, of which 14 patients underwent TVR concomitant LVAD. All TVR patients had moderate or severe baseline regurgitation. Crude survival was not different between groups. In multivariable models adjusted for confounding factors, TVR showed a significant association with improved survival (HR = 0.1, p = 0.049). Adjusted models showed no difference in RVF. CONCLUSIONS: In this cohort of patients, TVR at the time of LVAD implantation appears associated with better survival. Additional larger studies are needed to verify the effect of TVR at the time of LVAD implantation, and whether it should be utilized more frequently.

Continuous-flow left ventricular assist device implantation as a bridge to transplantation or destination therapy: racial disparities in outcomes.

BACKGROUND: There is a paucity of data assessing racial disparities in outcomes after left ventricular assist device (LVAD) implantation. This may be due to the relatively low percentage of African American (AA) patients at a given center. Given the high proportion of AAs in our patient population, we sought to evaluate outcomes of LVAD implantation in AAs vs Caucasians. METHODS: We stratified 88 LVAD patients by AA or Caucasian race. Variables were compared using 2-sided t-tests, chi-square tests, Cox proportional hazards models, and log-rank tests to determine whether a difference existed between AAs and Caucasians and whether race was a significant independent predictor of outcome. RESULTS: AAs represented 36.4% (32 of 88) of our LVAD patients. The two groups did not differ significantly in the incidence of hypertension, diabetes, or chronic renal insufficiency, reoperation rates, pre-operative body mass index, left ventricular ejection fraction, central venous pressure, pulmonary capillary wedge pressure, pulmonary artery pressure, or right ventricular function. Compared with Caucasians, AAs were significantly younger (48.6 vs 54.8 years, p = 0.019), and had a significantly higher mean body surface area (p = 0.009) and a higher rate of non-ischemic dilated cardiomyopathy (61% vs 39%, p = 0.008). No significant difference was found in 30-day (p = 0.12), 180-day (p = 0.166), or 360-day (p = 0.18) survival. Analysis by univariate Cox proportional hazard models (hazard ratio [95% confidence interval]) showed race was not an independent predictor of 30-day (4.5 [0.56-35.94], p = 0.157), 180-day (3.9 [0.48-31.95], p = 0.2), or 360-day survival (1.8 [0.6-5.71], p = 0.286). Age and pre-operative renal failure were the only independent predictors of survival at 30 days (1.1 [1.02-1.19], p = 0.019; 4.99 [1.24-20], p = 0.023, respectively), 180 days (1.09 [1-1.18], p = 0.041; 4.14 [0.99-17.39], p = 0.05), and 360 days (1.05 [1-1.1], p = 0.044; 2.52 [0.94-6.75], p = 0.05). Analysis by a multivariate logistic regression model showed age and chronic renal failure were no longer statistically significant for survival at 30, 180, and 360 days. CONCLUSIONS: Although multiple studies have demonstrated that AAs experience worse outcomes after coronary artery bypass grafting, heart transplantation, and valve surgery, we did not find similar results in our LVAD population. More rigorous pre-operative LVAD workup, including an evaluation by a multidisciplinary team, along with more intense post-operative follow-up, may explain improved outcomes in AAs after LVAD implantation compared with other cardiac surgical procedures, although additional analysis is required.

Impact of concomitant cardiac procedures performed during implantation of long-term left ventricular assist devices.

BACKGROUND: There is a paucity of data evaluating the effect of performing a concomitant cardiac procedure (CCP) on peri-operative survival in patients undergoing implantation of long-term left ventricular assist devices (LVADs). The objective of this study was to review our single-institutional experience with patients who underwent a CCP during implantation of a long-term continuous-flow LVAD. METHODS: From March 2006 through June 2012, 130 patients underwent implantation of a LVAD. Of these, 76 (58.5%) were implanted as bridge-to-transplant and 54 (41.5%) as destination therapy. The LVAD implantation was isolated in 95 patients and with CCP in 35. This included 19 tricuspid valve repairs, 14 aortic valve repair/replacements, and 2 patent foramen ovale closures. The LVAD only and LVAD+CCP groups were compared regarding pre-operative demographics, peri-operative and midterm survival, and the incidence of post-operative complications. RESULTS: Pre-operative central venous pressure (p = 0.047), moderate to severe tricuspid regurgitation (p = 0.011), cardiopulmonary bypass time (p < 0.0001), cross-clamp time (p < 0.0001), and right ventricular end diastolic diameter (p = 0.039) were higher in the CCP group. Body mass index (p = 0.01) and body surface area (p = 0.037) were higher in the LVAD-only group. Peri-operative and midterm survival at 30 days, 6 months, 1 year, and 2 years was 94%, 87%, 80%, and 73%, respectively, for isolated LVAD implants vs. 97%, 90%, 86%, and 86%, respectively, for LVAD+CCP (p = NS). Survival was similar for LVAD patients with tricuspid valve repairs, with aortic valve repair, and with patent foramen ovale repair (p = NS). Cox proportional hazard models showed a CCP was not an independent predictor of outcome (p = NS). CONCLUSIONS: CCPs performed during implantation of a long-term continuous-flow LVADs does not increase peri-operative or mid-term mortality. In addition, unlike previous reports, there was no additive procedural risk for patients undergoing concomitant aortic valve repair or replacement.

Ischemic versus nonischemic dilated cardiomyopathy: the implications of heart failure etiology on left ventricular assist device outcomes.

The effect of heart failure etiology on outcomes after left ventricular assist device (LVAD) implantation has not been fully investigated. The aim of this study was to compare postoperative survival, incidence of LVAD-related complications, left and right heart catheterizations, and echocardiographic findings in patients with ischemic cardiomyopathy (ICM) and nonischemic dilated cardiomyopathy (NIDCM) who underwent continuous-flow LVAD implantation. A total of 100 patients underwent implantation of a HeartMate II (Thoratec Corp., Pleasanton, CA) or HeartWare (HeartWare Inc., Framingham, MA) LVAD at our institution. Patients were stratified into two groups based on the etiology of heart failure, ICM and NIDCM. We identified 34 (34.0%) patients with ICM and 66 (66.0%) with NIDCM. Patients with ICM were significantly older (59.5 vs. 49.3; p < 0.001) and had higher rates of hypertension (91.2% vs. 84.8%; p = 0.021), chronic renal insufficiency (38.2% vs. 25.8%; p < 0.001), peripheral vascular disease (11.8% vs. 10.6%; p = 0.015), and previous cardiac surgery (58.8% vs. 13.6%; p < 0.001). Survival was similar for both groups with 30 day, 6 month, and 1 year survivals of 94.1%, 85.3%, and 82.4%, respectively, for ICM patients versus 95.5%, 92.4%, and 89.4%, respectively, for NIDCM patients (p = 0.743). Etiology of heart failure was not an independent predictor of survival in multivariate logistic regression analysis (p = 0.505). Post-LVAD complications and improvements in postoperative hemodynamic measurements were also similar for both groups. The etiology of heart failure did not appear to affect postoperative outcomes significantly.

Impact of continuous-flow left ventricular assist device support on right ventricular function.

BACKGROUND: Continuous-flow (CF) pumps have yielded improvements in short- and long-term survival and quality of life, and have reduced the number of left ventricular assist device (LVAD)-related complications. However, their ability to unload the right ventricle (RV) and improve RV function has not been as clearly defined. We evaluated the short- and mid-term effects of CF-LVADs on central venous pressure (CVP), pulmonary artery pressures (PAP), pulmonary capillary wedge pressure (PCWP), cardiac index (CI), RV ejection fraction (RVEF), RV end-diastolic dimension (RVEDD), RV stroke work index (RVSWI), tricuspid annular plane systolic excursion (TAPSE) and severity of tricuspid regurgitation (TR). METHODS: From March 2006 through June 2012, 130 patients with chronic heart failure underwent implantation of a CF-LVAD (122 HeartMate II and 8 HeartWare devices) as a bridge to transplant (n = 76) or as destination therapy (n = 54). Patients with pre-operative long-term LVADs (n = 4) and patients who underwent concomitant tricuspid valve repairs during their LVAD implant (n = 21) were excluded from the analysis. Echocardiograms and right heart catheterizations of the remaining 105 patients were reviewed pre-operatively and at 1 and 6 months post-LVAD implantation. RESULTS: At 1 month post-LVAD implantation, CVP decreased from 12.4 ± 5.9 mm Hg to 8.7 ± 4.5 mm Hg (p < 0.001), systolic PAP decreased from 52.3 ± 14.1 mm Hg to 36.8 ± 11.3 mm Hg (p < 0.001), PCWP decreased from 23.0 ± 9.4 mm Hg to 12.9 ± 8.0 mm Hg (p < 0.001), CI index increased from 1.8 ± 0.5 liters/min m2 to 2.4 ± 0.5 liters/min m2 (p < 0.001), RVEF increased from 33.1 ± 4.9% to 40.4 ± 6.2% (p < 0.001), RVEDD decreased from 36 mm to 31 mm (p = 0.020), RVSWI improved from 408.6 ± 144.6 mm Hg ml m2 to 614.4 ± 196.2 mm Hg ml m2 (p < 0.001), and mean TAPSE increased from 1.1 ± 0.4 cm to 1.9 ± 0.4 cm (p = 0.004). Similarly, qualitative RV function on echocardiography improved from 57.1% moderately or severely reduced pre-operatively to 38.1% at 1 month (p = 0.008). Severity of TR decreased from 11.4% moderate or severe pre-operatively to 4.8% at 1 month (p < 0.001). These improvements were maintained at 6 months post-LVAD. CONCLUSIONS: CF-LVAD support significantly decreased CVP and RVEDD, with concomitant improvement in RV function, as measured by increases in RVEF, RVSWI and TAPSE, as well as improvements in the qualitative echocardiographic appearance of RV contractility and a reduction in TR.

Patients with low compared with high body mass index gain more weight after implantation of a continuous-flow left ventricular assist device.

BACKGROUND: Patterns of weight change after implantation of a continuous-flow left ventricular assist device (CF-LVAD) can affect transplant candidacy and may influence outcomes. We evaluated changes in weight over a 24-month period from a national LVAD clinical trial database. METHODS: A retrospective analysis was performed of 896 patients enrolled into the HeartMate II Clinical trials for bridge-to-transplant and destination therapy from March 2005 to January 2009. The patients were divided into 4 groups: underweight (body mass index [BMI] <18.5 [kg/m(2)]); normal (BMI 18.5 to 29.9); obese (BMI 30 to 34.9); and extremely obese (BMI ≥ 35). Baseline BMI was compared with BMI at 6 months and 24 months after implant. BMI change >10% of baseline was considered clinically significant. RESULTS: At 6 months, underweight and normal-weight patients had significant increases in BMI, with effects sustained up to 24 months (p < 0.01). Underweight patients gained weight most often, with 75% showing clinically meaningful weight gain at 24 months. Obese and extremely obese patients, in contrast, did not experience weight change over the same period. Pre-albumin levels improved from baseline to 6 months in all patients. CONCLUSIONS: Underweight and normal-weight patients had an increase in BMI after LVAD implantation, and these changes persisted through 24 months. The BMIs of obese and extremely obese patients remained unchanged. Nutritional status improved in all groups.

Modified central closure technique for treatment of aortic insufficiency in patients on left ventricular assist device support.

Development of aortic insufficiency (AI) in a patient with a continuous flow left ventricular assist device (CF-LVAD) represents a serious complication. The circulatory loop that is created by the AI can lead to cardiogenic shock, malperfusion, and multisystem organ failure. The central closure technique has been well described and is a popular method of repairing the aortic valve in CF-LVAD patients with AI. Because of an early failure using this technique, we developed a modification of this technique that we describe in this report that can be particularly useful when the aortic valve leaflet tissue is relatively normal or thin, as opposed to thickened/fibrosed, as the strength of the repair is not solely provided by the central coaptation point of the leaflets, but is rather, distributed more diffusely across the leaflets.

An exploratory study of sleep quality, daytime function, and quality of life in patients with mechanical circulatory support.

PURPOSE: To identify and describe: (1) characteristics of sleep quality, daytime sleepiness, and quality of life (QOL) pre and post implantation of a left ventricular assist device (LVAD); (2) changes in sleep quality, daytime sleepiness, and QOL at baseline and 6 months post implant; and (3) relationships among the sleep quality, daytime sleepiness, and QOL variables. METHODS: We employed an exploratory research design. Fifteen patients with continuous/non-pulsatile flow LVAD consented to partake in the study. However, only 12 patients completed the baseline and 6-month post-LVAD implant data. We used the Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and Minnesota Living with Heart Failure Questionnaire (MLHFQ) to measure study variables. Data were analyzed using IBM SPSS 19.0 software. RESULTS: Patients reported worse sleep quality accompanied by daytime sleepiness particularly at baseline, and persisting up to 6 months post LVAD implant. A significant improvement in QOL was observed at 6 months post implant, but remained at poor levels. Correlations among sleep disturbance and daytime dysfunction components of PSQI and global daytime sleepiness (ESS) with QOL were strong (Pearson's correlations r >.60; p values < .05). CONCLUSIONS: We report the first empirical data describing the characteristics and correlations among sleep quality, daytime sleepiness, and QOL in patients with LVADs. Our findings offer beginning evidence about the sleep-QOL connection in this population which warrants attention in clinical practice and research. Further research is required to clearly elucidate these phenomena in patients with mechanical circulatory support and other implantable artificial organs.