The outcomes of transcatheter aortic valve replacement in a cohort of patients with end-stage renal disease.

OBJECTIVES: To examine whether transcatheter aortic valve replacement (TAVR) is a safe and effective treatment option for aortic stenosis in patients with end-stage renal disease (ESRD). BACKGROUND: Patients with ESRD undergoing surgical aortic valve replacement have an operative mortality approaching 20% and a 10-year survival of approximately 12%. We investigated whether TAVR is a more reasonable option. METHODS: This is a multicenter, retrospective study of all patients with ESRD who underwent TAVR in 8 institutions between 12/2011 and 02/2013. Demographic characteristics, mortality, major, and minor complications were evaluated. Outcomes were stratified by operative approach. RESULTS: Forty-three patients with a mean age 76.2 ± 11.0 years and a mean STS predicted risk of mortality of 15.53 ± 8.70% underwent TAVR. Mean duration of dialysis was 45.2 ± 52.3 months (median 29.5 months). Transfemoral (TF) TAVR was performed in 31/43 (72.1%), transapical in 11/43 (25.6%), and transaortic in 1/43 (2.3%). Operative mortality was 14.0% (6/43) with TF mortality 6.5% (2/31) and 33.3% (4/12) in non-TF patients. Six-month mortality was 11/43 (25.6%: 16.1% TF, 50.0% non-TF). Complications included stroke in 2.3% (1/43) and life-threatening or major bleeding in 14.0% (6/43). Discharge to another healthcare facility was 27.0% (10/37). Readmission within 30 days of procedure for any cause was 18.9% (7/37). CONCLUSIONS: Patients with ESRD who undergo TAVR are at high risk for mortality and complications. TAVR outcomes are comparable to but not substantially better than those with SAVR. Transfemoral TAVR seems to be at least as safe and effective as the current standard SAVR in patients undergoing aortic valve replacement. © 2016 Wiley Periodicals, Inc.

Operative strategies to reduce cerebral embolic events during on- and off-pump coronary artery bypass surgery: A stratified, prospective randomized trial.

OBJECTIVE: To determine the impact of different aortic clamping strategies on the incidence of cerebral embolic events during coronary artery bypass grafting (CABG). METHODS: Between 2012 and 2015, 142 patients with low-grade aortic disease (epiaortic ultrasound grade I/II) undergoing primary isolated CABG were studied. Those undergoing off-pump CABG were randomized to a partial clamp (n = 36) or clampless facilitating device (CFD; n = 36) strategy. Those undergoing on-pump CABG were randomized to a single-clamp (n = 34) or double-clamp (n = 36) strategy. Transcranial Doppler ultrasonography (TCD) was performed to identify high-intensity transient signals (HITS) in the middle cerebral arteries during periods of aortic manipulation. Neurocognitive testing was performed at baseline and 30-days postoperatively. The primary endpoint was total number of HITS detected by TCD. Groups were compared using the Mann-Whitney U test. RESULTS: In the off-pump group, the median number of total HITS were higher in the CFD subgroup (30.0; interquartile range [IQR], 22-43) compared with the partial clamp subgroup (7.0; IQR, 0-16; P < .0001). In the CFD subgroup, the median number of total HITS was significantly lower for patients with 1 CFD compared with patients with >1 CFD (12.5 [IQR, 4-19] vs 36.0 [IQR, 25-47]; P = .001). In the on-pump group, the median number of total HITS was 10.0 (IQR, 3-17) in the single-clamp group, compared with 16.0 (IQR, 4-49) in the double-clamp group (P = .10). There were no differences in neurocognitive outcomes across the groups. CONCLUSIONS: For patients with low-grade aortic disease, the use of CFDs was associated with an increased rate of cerebral embolic events compared with partial clamping during off-pump CABG. A single-clamp strategy during on-pump CABG did not significantly reduce embolic events compared with a double-clamp strategy.

Pneumonia after cardiac surgery: Experience of the National Institutes of Health/Canadian Institutes of Health Research Cardiothoracic Surgical Trials Network.

RATIONALE: Pneumonia remains the most common major infection after cardiac surgery despite numerous preventive measures. OBJECTIVES: To prospectively examine the timing, pathogens, and risk factors, including modifiable management practices, for postoperative pneumonia and estimate its impact on clinical outcomes. METHODS: A total of 5158 adult cardiac surgery patients were enrolled prospectively in a cohort study across 10 centers. All infections were adjudicated by an independent committee. Competing risk models were used to assess the association of patient characteristics and management practices with pneumonia within 65 days of surgery. Mortality was assessed by Cox proportional hazards model and length of stay by a multistate model. MEASUREMENTS AND MAIN RESULTS: The cumulative incidence of pneumonia was 2.4%, 33% of which occurred after discharge. Older age, lower hemoglobin level, chronic obstructive pulmonary disease, steroid use, operative time, and left ventricular assist device/heart transplant were risk factors. Ventilation time (24-48 vs ≤24 hours; hazard ratio [HR], 2.83; 95% confidence interval [95% CI], 1.72-4.66; >48 hours HR, 4.67; 95% CI, 2.70-8.08), nasogastric tubes (HR, 1.80; 95% CI, 1.10-2.94), and each unit of blood cells transfused (HR, 1.16; 95% CI, 1.08-1.26) increased the risk of pneumonia. Prophylactic use of second-generation cephalosporins (HR, 0.66; 95% CI, 0.45-0.97) and platelet transfusions (HR, 0.49, 95% CI, 0.30-0.79) were protective. Pneumonia was associated with a marked increase in mortality (HR, 8.89; 95% CI, 5.02-15.75) and longer length of stay of 13.55 ± 1.95 days (bootstrap 95% CI, 10.31-16.58). CONCLUSIONS: Pneumonia continues to impose a major impact on the health of patients after cardiac surgery. After we adjusted for baseline risk, several specific management practices were associated with pneumonia, which offer targets for quality improvement and further research.

The tip of the iceberg: financial liability analysis and clinical trials.

If your organization is involved in clinical trials, it is important to minimize the financial liability exposure associated with them by: Determining the level of research activity in your organization. Deciding who should be involved in conducting the financial analysis. Creating a dedicated financial liability analysis team. Providing training in regulations related to clinical trials. Developing standard operating procedures related to clinical trials.

Readmissions after cardiac surgery: experience of the National Institutes of Health/Canadian Institutes of Health research cardiothoracic surgical trials network.

BACKGROUND: Readmissions are a common problem in cardiac surgery. The goal of this study was to examine the frequency, timing, and associated risk factors for readmission after cardiac operations. METHODS: A 10-center cohort study prospectively enrolled 5,158 adult cardiac surgical patients (5,059 included in analysis) to assess risk factors for infection after cardiac operations. Data were also collected on all-cause readmissions occurring within 65 days after the operation. Major outcomes included the readmission rate stratified by procedure type, cause of readmission, length of readmission stay, and discharge disposition after readmission. Multivariable Cox regression was used to determine risk factors for time to first readmission. RESULTS: The overall rate of readmission was 18.7% (number of readmissions, 945). When stratified by the most common procedure type, readmission rates were isolated coronary artery bypass grafting, 14.9% (n = 248); isolated valve, 18.3% (n = 337); and coronary artery bypass grafting plus valve, 25.0% (n = 169). The three most common causes of first readmission within 30 days were infection (17.1% [n = 115]), arrhythmia (17.1% [n = 115]), and volume overload (13.5% [n = 91]). More first readmissions occurred within 30 days (80.6% [n = 672]) than after 30 days (19.4% [n = 162]), and 50% of patients were readmitted within 22 days from the index operation. The median length of stay during the first readmission was 5 days. Discharge in 15.8% of readmitted patients (n = 128) was to a location other than home. Baseline patient characteristics associated with readmission included female gender, diabetes mellitus on medication, chronic obstructive pulmonary disease, elevated creatinine, lower hemoglobin, and longer operation time. More complex surgical procedures were associated with an increased risk of readmission compared with the coronary artery bypass grafting group. CONCLUSIONS: Nearly 1 of 5 patients who undergo cardiac operations require readmission, an outcome with significant health and economic implications. Management practices to avert in-hospital infections, reduce postoperative arrhythmias, and avoid volume overload offer important targets for quality improvement.

Lessons learned from robotic-assisted coronary artery bypass surgery: risk factors for conversion to median sternotomy.

OBJECTIVE: Robotic-assisted coronary artery bypass is a minimally invasive alternative to traditional coronary artery bypass surgery via median sternotomy with an associated learning curve. The purpose of this study was to investigate the reasons for conversion to sternotomy. METHODS: From October 2009 to June 2012, two surgeons at one US academic institution performed 271 consecutive robotic-assisted coronary artery bypass procedures. For all cases, isolated, off-pump left internal mammary artery (LIMA) to left anterior descending coronary artery grafting was planned via a 3- to 4-cm sternal-sparing thoracotomy after robotic internal mammary artery harvest and pericardiotomy. RESULTS: Conversion to sternotomy occurred in 15 of 271 (5.5%) patients. The most common reason was technical difficulty with the anastomosis, which occurred in 6 (40.0%) patients. Others included LIMA dissection, 2 (13.3%); wrong vessel grafted, 2 (13.3%); ventricular fibrillation and cardiac arrest, 1 (6.7%); equipment malfunction, 1 (6.7%); adhesions, 1 (6.7%); and other. Two underwent emergent conversion. Six underwent multivessel bypass after conversion instead of hybrid coronary revascularization. No mortality occurred among converted patients. Two patients had postoperative myocardial infarction and one had a superficial sternal wound infection. Conversion rate was relatively stable among the four different time quartiles (range, 3.0%-7.4%), although the reasons for conversion were different. CONCLUSIONS: Conversion to sternotomy is an infrequent complication of robotic-assisted coronary artery bypass, most commonly because of technical difficulties during the LIMA harvest and the LIMA to left anterior descending anastomosis. Anatomic and patient variables as well as inherent technical problems with minimally invasive procedures make conversion unavoidable in some patients.

Off-pump and on-pump coronary artery bypass grafting are associated with similar graft patency, myocardial ischemia, and freedom from reintervention: long-term follow-up of a randomized trial.

BACKGROUND: The Surgical Management of Arterial Revascularization Therapies trial was conceived to rigorously compare completeness of revascularization, clinical outcomes and resource utilization in unselected patients referred for elective, primary coronary artery bypass grafting randomly assigned to undergo off-pump (OPCAB) or conventional on-pump coronary artery bypass grafting using cardiopulmonary bypass (CPB). The goal of this follow-up study was to compare long-term survival, graft patency, myocardial ischemia, and clinical outcomes among survivors who volunteered to return for clinical evaluation and imaging studies. METHODS: Two hundred unselected patients with multivessel coronary artery disease were randomly assigned to OPCAB or CPB coronary artery bypass grafting between March 2000 and August 2001. All-cause mortality was determined by individual patient contact and referencing the Social Security Death Master File. Of 140 survivors, 87 volunteered to return after a minimum of 6.8 years (maximum, 8.4 years; mean, 7.5 years) for assessment of graft patency (computed tomographic angiography) and myocardial ischemia (cardiac positron emission tomography and 12-lead electrocardiogram). Age at follow-up ranged from 38 to 90 years (mean, 68 years). RESULTS: There were 26 deaths from all causes among OPCAB patients and 31 among CPB patients as of March 30, 2009. Graft patency was similar between groups among 622 grafts assessed by angiography before hospital discharge (99% OPCAB versus 97.7% CPB; p=0.22, Fisher's exact test), among 511 grafts assessed by angiography at 1 year (93.6% OPCAB versus 95.8% CPB; p=0.33), and among 190 grafts assessed by computed tomographic angiography at late follow-up (76% OPCAB versus 83.5% CPB; p=0.44). Twelve of 34 OPCAB (35.3%) and 16 of 39 CPB patients (41.0%) had any ischemia on positron emission tomography scanning (p=0.62). Four OPCAB patients (11.8%) and 9 CPB patients (23.1%) had an ischemic region in excess of 10% of myocardium (p=0.21). At late follow-up, recurrent angina had occurred in 11 of 43 (25.6%) OPCAB patients and 5 of 44 (11.4%) CPB patients (p=0.09). Percutaneous reintervention had been performed at the discretion of blinded local cardiologists in 1 of 43 (2.3%) OPCAB patients and 1 of 44 (2.3%) CPB patients (p=1.0). No patient in either group has undergone repeat CABG. CONCLUSIONS: In this randomized trial, off-pump and on-pump coronary artery bypass grafting were associated with similar early and late graft patency, incidence of recurrent or residual myocardial ischemia, need for reintervention, and long-term survival.

Intraoperative epiaortic ultrasound scanning guides operative strategies and identifies patients at high risk during coronary artery bypass grafting.

OBJECTIVE: : Epiaortic ultrasound (EU) reliably reveals ascending aortic atherosclerosis (AAA), allowing strategies to minimize the risk of embolization or plaque disruption during coronary artery bypass grafting. Our objective was to delineate if EU-guided intervention improved outcomes. METHODS: : Patients undergoing coronary artery bypass grafting (2004-2007) were categorized by EU grade (grade 1-2 [mild] vs. 3-5 [moderate/severe]) and the use of an aortic clamp. A propensity score estimated probability of clamp use was based on 45 risk factors. Multiple logistic regression models measured the association between outcomes-death, stroke, myocardial infarction, and major adverse cardiac and cerebrovascular events (MACCE)-and the primary variables (grade and clamp use), adjusted for propensity score. RESULTS: : Grade was available in 4278 patients. Patients with grade 3 to 5 AAA had an increased risk of death (adjusted odds ratios (AOR) 3.11; P < 0.001), stroke (AOR 2.12; P < 0.001), and MACCE (AOR 2.58; P < 0.001). Aortic clamping (any clamp, all grades) led to a higher risk of stroke (AOR 2.77; P = 0.032). EU altered aortic manipulation in 530 patients (12.4%). In this group, patients with high grade aortas had similar rates of death, stroke or MACCE, when compared with patients with low-grade aortas. CONCLUSIONS: : EU alters surgical strategy. Patients with grade 3 to 5 AAA are at increased risk of death, stroke, and MACCE compared with patients with grade 1 to 2 AAA. Clamping the aorta (any grade) increases the risk for stroke. Aortic clamping should be avoided in patients with grade 3 to 5 AAA, but EU may minimize morbidity and mortality if a clamp must be used.

Influence of on-pump versus off-pump techniques and completeness of revascularization on long-term survival after coronary artery bypass.

BACKGROUND: Off-pump coronary artery bypass graft surgery (OPCABG) may be associated with reduced morbidity and in-hospital mortality. In this study, we report the influence of surgery type, number of grafts, and the Index of Completeness of Revascularization (ICOR), namely, the number of grafts/number diseased vessel systems, on long-term survival. METHODS: From 1997 to 2006, 12,812 consecutive patients underwent isolated CABG at a single academic center. Ten-year survival data were obtained by cross-referencing patients with the national Social Security Death Index. A propensity score analysis of 46 preoperative characteristics balanced risk factors between surgical groups. A proportional hazards regression analysis modeled the hazard of death as a function of surgery type (on versus off), distal group (1 to 3 versus 4 to 7 vessels), ICOR, and propensity score. RESULTS: Proportional hazards regression analysis showed no significant influence of surgery type or number of grafts on long-term survival within the four groups: OPCABG 1 to 3 grafts (n = 3,946; ICOR 1.11), OPCABG 4 to 7 grafts (n = 1,721; ICOR 1.56), on-pump CABG 1 to 3 grafts (n = 3,380; ICOR 1.21), and on-pump CABG 4 to 7 grafts (n = 3,765; ICOR 1.64). Irrespective of technique of revascularization, there was a survival advantage for patients with higher ICOR. CONCLUSIONS: Long-term survival was similar for patients receiving 1 to 3 or 4 to 7 grafts by either on-pump or off-pump techniques. However, higher ICOR was associated with improved long- term survival within all groups.