Yan Topilsky

Incidence of Aortic Complications in Patients With Bicuspid. Aortic Valves

CONTEXT Bicuspid aortic valve (BAV), the most common congenital heart defect, has been thought to cause frequent and severe aortic complications; however, long-term, population-based data are lacking. OBJECTIVE To determine the incidence of aortic complications in patients with BAV in a community cohort and in the general population. DESIGN, SETTING, AND PARTICIPANTS In this retrospective cohort study, we conducted comprehensive assessment of aortic complications of patients with BAV living in a population-based setting in Olmsted County, Minnesota. We analyzed long-term follow-up of a cohort of all Olmsted County residents diagnosed with definite BAV by echocardiography from 1980 to 1999 and searched for aortic complications of patients whose bicuspid valves had gone undiagnosed. The last year of follow-up was 2008-2009. MAIN OUTCOME MEASURE Thoracic aortic dissection, ascending aortic aneurysm, and aortic surgery. RESULTS The cohort included 416 consecutive patients with definite BAV diagnosed by echocardiography, mean (SD) follow-up of 16 (7) years (6530 patient-years). Aortic dissection occurred in 2 of 416 patients; incidence of 3.1 (95% CI, 0.5-9.5) cases per 10,000 patient-years, age-adjusted relative-risk 8.4 (95% CI, 2.1-33.5; P = .003) compared with the countys general population. Aortic dissection incidences for patients 50 years or older at baseline and bearers of aortic aneurysms at baseline were 17.4 (95% CI, 2.9-53.6) and 44.9 (95% CI, 7.5-138.5) cases per 10,000 patient-years, respectively. Comprehensive search for aortic dissections in undiagnosed bicuspid valves revealed 2 additional patients, allowing estimation of aortic dissection incidence in bicuspid valve patients irrespective of diagnosis status (1.5; 95% CI, 0.4-3.8 cases per 10,000 patient-years), which was similar to the diagnosed cohort. Of 384 patients without baseline aneurysms, 49 developed aneurysms at follow-up, incidence of 84.9 (95% CI, 63.3-110.9) cases per 10,000 patient-years and an age-adjusted relative risk 86.2 (95% CI, 65.1-114; P <.001 compared with the general population). The 25-year rate of aortic surgery was 25% (95% CI, 17.2%-32.8%). CONCLUSIONS In the population of patients with BAV, the incidence of aortic dissection over a mean of 16 years of follow-up was low but significantly higher than in the general population.

Readmissions after implantation of axial flow left ventricular assist device.

OBJECTIVES The purpose of this study was to determine the occurrence and causes of readmissions after implantation of axial flow left ventricular assist device (LVAD). BACKGROUND Based on the REMATCH (Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure) study experience, readmissions after LVAD implantation are thought to be frequent. METHODS We retrospectively analyzed admissions to our facility in a cohort of 115 patients implanted between January 2008 and July 2011 with the HeartMate II axial flow LVAD, of whom 42 were bridged to transplant. To account for repeated events, Andersen-Gill models were used to determine possible predictors. RESULTS The patients were followed for 1.4 ± 0.9 years. There were 224 readmissions in 83 patients. The overall readmission rate was 1.64 ± 1.97 per patient-year of follow-up. The readmission rate for the first 6 months was 2.0 ± 2.3 and decreased to 1.2 ± 2.1 during subsequent follow-up. Leading causes were bleeding (66 readmissions in 34 patients), mostly gastrointestinal bleed (51 in 27 patients), cardiac (51 in 36 patients, most for HF or arrhythmia), infections (32 in 25 patients) of which 6 were pump related, and thrombosis (20 in 15 patients) including 13 readmissions due to hemolysis. Preoperative variables associated with (fewer) readmissions in a multivariate model include residence within our hospital-extended referral zone of Minnesota and the neighboring states (hazard ratio: 0.66; 95% confidence interval: 0.48 to 0.91; p = 0.011), hemoglobin (hazard ratio: 0.91, 95% confidence interval: 0.84 to 0.99; p = 0.027) and N-terminal pro-B-type natriuretic peptide (hazard ratio: 0.98; 95% confidence interval: 0.96 to 1.0 per 1,000-unit increase, p = 0.022). C-statistic for the model: 0.63. CONCLUSIONS Readmission rates after axial flow LVAD implantation decrease during the first 6 months and then stabilize. The leading causes are bleeding, cardiac (heart failure and arrhythmia), infections, and thrombosis.

Impact of Left Atrial Volume on Clinical Outcome in Organic Mitral Regurgitation

OBJECTIVES The purpose of this paper was to assess the link between left atrial (LA) volume at diagnosis and outcome of patients with mitral regurgitation (MR). BACKGROUND Left atrial enlargement is a consequence of organic MR, but its association with clinical outcome independently of MR severity is uncertain. METHODS We prospectively enrolled 492 patients (age 63 +/- 15 years, 60% men) in sinus rhythm with organic MR (regurgitant volume 68 +/- 42 ml/beat) and performed at baseline triple echocardiographic quantitation (MR severity, LA volume, and left ventricular characteristics). Outcome with medical and surgical management was analyzed. RESULTS Left atrial volume indexed to body surface area (LA index) was 55 +/- 26 ml/m(2) (<40 ml/m(2) in 158 patients, 40 to 59 ml/m(2) in 160 patients, and > or =60 ml/m(2) in 174 patients). Under medical management, 5-year survival was 80 +/- 2.9% and cardiac events 28 +/- 3%. Adjusting for established predictors of outcome, LA index was independently associated with survival after diagnosis (hazard ratio [HR]: 1.3 [95% confidence interval (CI): 1.1 to 1.5] per 10 ml/m(2) increment, p = 0.001). Patients with LA index > or =60 ml/m(2) had lower 5-year survival than those with no or mild LA enlargement (p < 0.0001) and than the rates of survival expected in the U.S. population (53 +/- 8.6% vs. 76%, p = 0.017). Compared with patients with LA index <40 ml/m(2), those with LA index > or =60 ml/m(2) had increased mortality (HR: 2.8 [95% CI: 1.2 to 6.5], p = 0.016) and cardiac events (HR: 5.2 [95% CI: 2.6 to 10.9], p < 0.0001) with medical management. Mitral surgery was associated with decreased mortality (HR: 0.46 [95% CI: 0.26 to 0.84], p = 0.01) and cardiac events (HR: 0.38 [95% CI: 0.23 to 0.62], p = 0.0001) and after surgery patients with LA index > or =60 ml/m(2) versus <60 ml/m(2) did not incur excess mortality or cardiac events (both p > 0.30). CONCLUSIONS In organic MR, LA index at diagnosis predicts long-term outcome, incrementally to known predictors of outcome. This marker of risk is particularly important because mitral surgery in these patients markedly improves outcome and restores life expectancy. LA index should be measured in routine clinical practice for risk-stratification and for clinical decision making in patients with organic MR.

Changes in renal function after implantation of continuous-flow left ventricular assist devices.

OBJECTIVES The aim of this study was to determine renal outcomes after left ventricular assist device (LVAD) implantation. BACKGROUND Renal dysfunction before LVAD placement is frequent, and it is unclear whether it is due to primary renal disease or to poor perfusion. METHODS A retrospective single-center analysis was conducted in 83 consecutive patients implanted with HeartMate II continuous-flow LVADs (Thoratec Corp., Pleasanton, California). Calculated glomerular filtration rate (GFR) was assessed on admission and 1, 3, and 6 months after implantation. To define predictors for improvement in GFR, clinical variables were examined in patients with decreased renal function (GFR <60 ml/min/1.73 m(2)) before LVAD, surviving and dialysis-free at 1 month (n = 44). RESULTS GFR significantly increased from admission (53.2 ± 21.4 ml/min/1.73 m(2)) to 1 month after LVAD implantation (87.4 ± 27.9 ml/min/1.73 m(2)) (p < 0.0001). Subsequently, at 3 and 6 months, GFR remained significantly (p < 0.0001) above pre-LVAD values. Of the 51 patients with GFRs <60 ml/min/1.73 m(2) before LVAD surviving at 1 month, 34 (67%) improved to GFRs >60 ml/min/1.73 m(2). Univariate pre-operative predictors for improvement in renal function at 1 month included younger age (p = 0.049), GFR improvement with optimal medical therapy (p < 0.001), intra-aortic balloon pump use (p = 0.004), kidney length above 10 cm (p = 0.023), no treatment with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (p = 0.029), higher bilirubin (p = 0.002), higher Lietz-Miller score (p = 0.019), and atrial fibrillation (p = 0.007). Multivariate analysis indicated pre-operative improved GFR (slope = 0.5 U per unit improved; 95% confidence interval: 0.2 to 0.8; p = 0.003), atrial fibrillation (slope = 27; 95% confidence interval: 8 to 46; p = 0.006), and intra-aortic balloon pump use (slope = 14; 95% confidence interval: 2 to 26; p = 0.02) as independent predictors. CONCLUSIONS In most patients with end-stage heart failure considered for LVAD implantation, renal dysfunction is reversible and likely related to poor renal perfusion.

Sirolimus as Primary Immunosuppression Attenuates Allograft Vasculopathy With Improved Late Survival and Decreased Cardiac Events After Cardiac Transplantation

Background— We retrospectively analyzed the potential of sirolimus as a primary immunosuppressant in the long-term attenuation of cardiac allograft vasculopathy progression and the effects on cardiac-related morbidity and mortality. Methods and Results— Forty-five cardiac transplant recipients were converted to sirolimus 1.2 years (0.2, 4.0) after transplantation with complete calcineurin inhibitor withdrawal. Fifty-eight control subjects 2.0 years (0.2, 6.5 years) from transplantation were maintained on calcineurin inhibitors. Age, sex, ejection fraction, and time from transplantation to baseline intravascular ultrasound study were not different (P>0.2 for all) between the groups; neither were secondary immunosuppressants and use of steroids. Three-dimensional intravascular ultrasound studies were performed at baseline and 3.1 years (1.3, 4.6 years) later. Plaque index progression (plaque volume/vessel volume) was attenuated in the sirolimus group (0.7±10.5% versus 9.3±10.8%; P=0.0003) owing to reduced plaque volume in patients converted to sirolimus early (<2 years) after transplantation (P=0.05) and improved positive vascular remodeling (P=0.01) in patients analyzed late (>2 years) after transplantation. Outcome analysis in 160 consecutive patients maintained on 1 therapy was performed regardless of performance of intravascular ultrasound examinations. Five-year survival was improved with sirolimus (97.4±1.8% versus 81.8±4.9%; P=0.006), as was freedom from cardiac-related events (93.6±3.2% versus 76.9±5.5%; P=0.002). Conclusions— Substituting calcineurin inhibitor with sirolimus as primary immunosuppressant attenuates long-term cardiac allograft vasculopathy progression and may improve long-term allograft survival owing to favorable coronary remodeling. Because of the lack of randomization and retrospective nature of our analysis, the differences in outcome should be interpreted cautiously, and prospective clinical trials are required.

Preoperative factors associated with adverse outcome after tricuspid valve replacement

Background— Preoperative factors associated with increased mortality and worse outcome after tricuspid valve replacement in patients with severe tricuspid regurgitation are poorly understood. Methods and Results— We retrospectively analyzed 189 patients (37% men; age, 67.5±11.3 years) who underwent tricuspid valve replacement for severe tricuspid regurgitation. Operative mortality rate was 10%, and was associated with intra-aortic balloon pump (odds ratio, 3.2; 95% confidence interval, 1.9 to 5.6; P<0.0001) or the presence of severe symptoms (New York Heart Association class IV relative to classes II and/or III) at the time of surgery (1.7; 95% confidence interval, 1.05 to 2.8; P=0.02). At the end of follow-up (29.3±27.1 months), 70 patients (37%) died, 6 (3%) needed tricuspid reoperation, and 41 (21.7%) were readmitted for heart failure. Seventy-eight patients (41.3%) were free from cardiovascular events (death, tricuspid reoperation, or heart failure admissions). The only echocardiographic parameter independently associated with adverse outcomes was a decrease in the right index of myocardial performance ratio. All-cause mortality was independently associated with a higher Charlson index (hazard ratio, 1.18; 95% confidence interval, 1.01 to 1.36; P=0.03), shorter right index of myocardial performance ratio (0.91; 95% confidence interval, 0.87 to 0.96; P=0.005), and preoperative New York Heart Association IV class (1.71; 95% confidence interval, 1.3 to 2.2; P<0.0001). In 68 patients with isolated tricuspid valve replacement, the associations between short right index of myocardial performance ratio, high Charlson index, New York Heart Association class IV, and increased mortality remained significant. Conclusions— Tricuspid valve replacement for severe tricuspid regurgitation can be performed with an acceptable operative mortality if patients undergo surgery before the onset of advanced heart failure symptoms. Late mortality is associated with a high preoperative Charlson index, short right index of myocardial performance ratio, and advanced New York Heart Association class.

Cardioband, a transcatheter surgical-like direct mitral valve annuloplasty system: early results of the feasibility trial

AIMS Cardioband system is a direct annuloplasty adjustable device that is implanted in the beating heart on the posterior annulus under fluoroscopic and transoesophageal echocardiographic (TEE) guidance. We report the early (1 month) outcomes of the first-in-man pre-CE-mark feasibility and safety trial. METHODS AND RESULTS The study enrolled high-risk adult individuals at five institutions in Europe with symptomatic secondary mitral regurgitation (MR) despite optimal medical therapy. The primary efficacy endpoints included the technical success rate of implantation, feasibility of the Cardioband adjustment (technical performance), and ability to reduce the annular septolateral dimension and MR grade at hospital discharge and at 30 days. The study group included 31 consecutively enrolled high-risk patients with moderate-to-severe or severe secondary MR with at least 1 month of follow-up (mean age 71.8 ± 6.9 years). All patients received the full implant of a Cardioband. Adjustment of the Cardioband resulted in a significant reduction in the septolateral dimension in all but two patients (septolateral dimension from 36.8 ± 4.8 to 29 ± 5.5 mm after the procedure, P < 0.01). Following Cardioband adjustment (29 of 31 patients) MR was none or trace in 6 (21%), mild in 21 (72%), and moderate in 2 (7%). No patient had severe MR after adjustment. Procedural mortality was zero and in-hospital mortality was 6.5% (2 of 31 patients, neither procedure- nor device-related). At 30 days, 22 of the 25 patients (88%) had MR ≤2+. CONCLUSIONS This study demonstrates the feasibility and safety of percutaneous direct mitral annuloplasty with the Cardioband device in high-risk patients with MR.

Echocardiographic Variables After Left Ventricular Assist Device Implantation Associated With Adverse Outcome

Background— Operative mortality after left ventricular assist device (LVAD) implantation is heavily influenced by patient selection and the technical difficulty of surgery. However, how we treat our patients and LVAD setting may affect the patient outcome beyond this period. We postulated that the presence of echocardiographic variables 1 month after surgery suggesting appropriate degree of LV unloading and an adequate forward flow would be important in determining clinical outcomes after the initial successful LVAD implantation. Methods and Results— We retrospectively analyzed various variables in echocardiographic examinations performed 30 days after LVAD implant in 76 consecutive patients receiving continuous flow device for their association with a compound end point (90-day mortality, readmission for heart failure, or New York Heart Association class III or higher at the end of the 90-day period). The echocardiographic associations examined included estimated LVAD flow, with and without native LV contribution, interventricular septal position, the status of aortic valve opening, an estimated left atrial pressure (ELAP), the mitral flow E-wave deceleration time, and the ratio of deceleration time to E-wave velocity (mitral deceleration index [MDI]). Four patients died during the 30- to 90-day period, 6 patients were readmitted for heart failure, and 25 patients were considered to have New York Heart Association class III or higher at the end of the 90-day period. Variables associated with adverse outcome included increased ELAP (odds ratio, 1.30 [1.16–1.48]; P<0.0001), MDI <2 ms/[cm/s] (odds ratio, 4.4 implantation [1.22–18]; P=0.02) and decreased tricuspid lateral annulus velocity (odds ratio, 0.70 implantation [0.48–0.95]; P=0.02). A leftward deviation of interventricular septum was associated with a worse outcome (odds ratio, 3.03 implantation [1.21–13.3]; P=0.01). Conclusions— Mortality and heart failure after LVAD surgery appear to be predominantly determined by echocardiographic evidence of inefficient unloading of the left ventricle and persistence of right ventricular dysfunction. Increased estimated LA pressure and short MDI are associated with worse mid term outcome. Leftward deviation of the septum is associated with worse outcome as well.Background —Operative mortality following LVAD implantation is heavily influenced by patient selection and the technical difficulty of surgery. However, how we manage our patients and LVAD setting may affect the patient outcome beyond this period. We postulated that the presence of echocardiographic variables one month after surgery suggesting appropriate degree of LV unloading and an adequate forward flow would be important in determining clinical outcomes following the initial successful LVAD implantation. Methods and Results —We retrospectively analyzed various variables in echocardiographic examinations performed 30 days after LVAD implant in 76 consecutive patients receiving continuous flow device (Heart Mate II) for their association with a compound endpoint (90 day mortality, re-admission for heart failure, or NYHA≥III at the end of the 90 day period). The echocardiographic associations examined included estimated LVAD flow, with and without native LV contribution, inter-ventricular septal position, the status of aortic valve opening, an estimated left atrial pressure (ELAP), the mitral flow E wave deceleration time and the ratio of deceleration time to E wave velocity (mitral deceleration index [MDI]). Four patients died during the 30-90 day period, six patients were re-admitted for heart failure, and 25 patients were considered to have NYHA≥III at the end of the 90 day period. Variables associated with adverse outcome included increased ELAP (Odds Ratio (OR) 1.30(1.16-1.48); p<0.0001), MDI<2 ms/ [cm/s] (OR 4.4(1.22-18); P=0.02) and decreased tricuspid lateral annulus velocity (OR 0.70(0.48-0.95); P=0.02). A leftward deviation of inter-ventricular septum was associated with a worse outcome (OR 3.03(1.21-13.3); P=0.01). Conclusions —Mortality and heart failure after LVAD surgery seem to be predominantly determined by echocardiographic evidence of inefficient unloading of left ventricle and persistence of RV dysfunction. Increased estimated LA pressure and short MDI are associated with worse mid term outcome. Leftward deviation of the septum is associated with worse outcome as well.

Echocardiographic predictors of adverse outcomes after continuous left ventricular assist device implantation.

OBJECTIVES The purpose of the study was to identify echocardiographic predictors of adverse outcome in patients implanted with continuous-flow left ventricular assist devices (LVAD). BACKGROUND Continuous flow LVAD have become part of the standard of care for the treatment of advanced heart failure. However, knowledge of echocardiographic predictors of outcome after LVAD are lacking. METHODS Overall, 83 patients received continuous-flow LVAD (HeartMate II, Thoratec Corporation, Pleasanton, California) from February 2007 to June 2010. The LVAD database, containing various echocardiographic parameters, was examined to analyze their influence on in-hospital mortality, a compound cardiac event (in-hospital mortality or acute right ventricular [RV] dysfunction), and long-term mortality. RESULTS Eight patients died before discharge (operative mortality 9.6%), and another 15 patients were considered to have acute RV dysfunction immediately after surgery. Patients with relatively small left ventricular end-diastolic diameters (<63 mm) had significantly higher risk for in-hospital mortality (odds ratio [OR]: 0.9; 95% confidence interval [CI]: 0.83 to 0.99; p = 0.04) or occurrence of the compound cardiac event (OR: 0.89; 95% CI: 0.84 to 0.95; p < 0.001). The most significant predictor of outcome was the decreased timing interval between the onset and the cessation of tricuspid regurgitation flow corrected for heart rate (TRDc), a surrogate for early systolic equalization of RV and right atrial pressure. Short TRDc predicted in-hospital mortality (OR: 0.85; 95% CI: 0.74 to 0.97; p = 0.01) and the compound cardiac event (OR: 0.83; 95% CI: 0.74 to 0.91; p < 0.0001). Multivariate analysis based on a logistic regression model demonstrated that the accuracy of predicting the 30-day compound adverse outcome was improved with the addition of echocardiographic variables when added to the commonly used hemodynamic or clinical scores. TRDc predicted long-term survival, with adjusted risk ratios of 0.89 for death from any cause (95% CI: 0.83 to 0.96; p = 0.003) and 0.88 for cardiac-related death (95% CI: 0.77 to 0.98; p = 0.03). CONCLUSIONS The presence of either a relatively small left ventricle (<63 mm) or early systolic equalization of RV and right atrial pressure (short TRDc) demonstrated by echocardiography is associated with increased 30-day morbidity and mortality. Prediction of early adverse outcomes by echocardiographic parameters is additive to laboratory or hemodynamic variables.

Echocardiographic Variables Post LVAD Associated with Adverse Outcome

Background— Operative mortality after left ventricular assist device (LVAD) implantation is heavily influenced by patient selection and the technical difficulty of surgery. However, how we treat our patients and LVAD setting may affect the patient outcome beyond this period. We postulated that the presence of echocardiographic variables 1 month after surgery suggesting appropriate degree of LV unloading and an adequate forward flow would be important in determining clinical outcomes after the initial successful LVAD implantation. Methods and Results— We retrospectively analyzed various variables in echocardiographic examinations performed 30 days after LVAD implant in 76 consecutive patients receiving continuous flow device for their association with a compound end point (90-day mortality, readmission for heart failure, or New York Heart Association class III or higher at the end of the 90-day period). The echocardiographic associations examined included estimated LVAD flow, with and without native LV contribution, interventricular septal position, the status of aortic valve opening, an estimated left atrial pressure (ELAP), the mitral flow E-wave deceleration time, and the ratio of deceleration time to E-wave velocity (mitral deceleration index [MDI]). Four patients died during the 30- to 90-day period, 6 patients were readmitted for heart failure, and 25 patients were considered to have New York Heart Association class III or higher at the end of the 90-day period. Variables associated with adverse outcome included increased ELAP (odds ratio, 1.30 [1.16–1.48]; P<0.0001), MDI <2 ms/[cm/s] (odds ratio, 4.4 implantation [1.22–18]; P=0.02) and decreased tricuspid lateral annulus velocity (odds ratio, 0.70 implantation [0.48–0.95]; P=0.02). A leftward deviation of interventricular septum was associated with a worse outcome (odds ratio, 3.03 implantation [1.21–13.3]; P=0.01). Conclusions— Mortality and heart failure after LVAD surgery appear to be predominantly determined by echocardiographic evidence of inefficient unloading of the left ventricle and persistence of right ventricular dysfunction. Increased estimated LA pressure and short MDI are associated with worse mid term outcome. Leftward deviation of the septum is associated with worse outcome as well.Background —Operative mortality following LVAD implantation is heavily influenced by patient selection and the technical difficulty of surgery. However, how we manage our patients and LVAD setting may affect the patient outcome beyond this period. We postulated that the presence of echocardiographic variables one month after surgery suggesting appropriate degree of LV unloading and an adequate forward flow would be important in determining clinical outcomes following the initial successful LVAD implantation. Methods and Results —We retrospectively analyzed various variables in echocardiographic examinations performed 30 days after LVAD implant in 76 consecutive patients receiving continuous flow device (Heart Mate II) for their association with a compound endpoint (90 day mortality, re-admission for heart failure, or NYHA≥III at the end of the 90 day period). The echocardiographic associations examined included estimated LVAD flow, with and without native LV contribution, inter-ventricular septal position, the status of aortic valve opening, an estimated left atrial pressure (ELAP), the mitral flow E wave deceleration time and the ratio of deceleration time to E wave velocity (mitral deceleration index [MDI]). Four patients died during the 30-90 day period, six patients were re-admitted for heart failure, and 25 patients were considered to have NYHA≥III at the end of the 90 day period. Variables associated with adverse outcome included increased ELAP (Odds Ratio (OR) 1.30(1.16-1.48); p<0.0001), MDI<2 ms/ [cm/s] (OR 4.4(1.22-18); P=0.02) and decreased tricuspid lateral annulus velocity (OR 0.70(0.48-0.95); P=0.02). A leftward deviation of inter-ventricular septum was associated with a worse outcome (OR 3.03(1.21-13.3); P=0.01). Conclusions —Mortality and heart failure after LVAD surgery seem to be predominantly determined by echocardiographic evidence of inefficient unloading of left ventricle and persistence of RV dysfunction. Increased estimated LA pressure and short MDI are associated with worse mid term outcome. Leftward deviation of the septum is associated with worse outcome as well.