Impact of Early, Low-Dose Factor VIIa on Subsequent Transfusions and Length of Stay in Cardiac Surgery.

OBJECTIVE: Recombinant factor VII (rFVIIa) is used to treat cardiac surgical bleeding in an off-label manner. However, optimal dosing and timing of administration to provide efficacious yet safe outcomes remain unknown. DESIGN: Retrospective, observational study. SETTING: Tertiary care academic center. PARTICIPANTS: Cardiac surgical patients (N = 214) who received low-dose rFVIIa for cardiac surgical bleeding. INTERVENTIONS: Patients were allocated into one of three groups based on timing of rFVIIa administration during the course of bleeding resuscitation based on the number of hemostatic products given before rFVIIa administration: group one = ≤one products (n = 82); group two = two-to-four products (n = 73); and group three= ≥five products (n = 59). MEASUREMENTS AND MAIN RESULTS: Patients who received low-dose rFVIIa later in the course of bleeding resuscitation (group three) had longer intensive care unit stays (p = 0.014) and increased incidence of postoperative renal failure when compared with group one (p = 0.039). Total transfusions were lowest in patients who received rFVIIa early in the course of resuscitation (group one) (median, two [interquartile range (IQR), 1-4.75]) and highest in group three (median, 11 [IQR, 8-14]; p < 0.001). Subsequent blood product transfusions after rFVIIa administration were highest in group two (p = 0.003); however, the median for all three groups was two products. There were no differences in thrombosis, reexplorations, or mortality in any of the groups. CONCLUSIONS: This study identified no differences in adverse outcomes based on timing of administration of low-dose rFVIIa for cardiac surgical bleeding defined by stage of resuscitation, but the benefits of early administration remain unclear.

Very low-dose recombinant Factor VIIa administration for cardiac surgical bleeding reduces red blood cell transfusions and renal risk: a matched cohort study.

Outcomes following administration of very-low-dose recombinant activated factor VIIa (vld-rFVIIa) for cardiac surgical bleeding remain debatable. We sought to determine the association of vld-rFVIIa and adverse surgical outcomes. Retrospective, cohort matching of patients undergoing cardiac surgery who received vld-rFVIIa (median 13.02 µg/kg) for perioperative bleeding were matched to cardiac surgical patients who had bleeding and received standard of care for bleeding without Factor VIIa administration. Of the 362 matched patients (182 in each group), patients who received rFVIIa required significantly less red blood cell transfusions [median 3 units (range 0--60, IQR = 4 units) versus 4 units (range 2-34, IQR = 4 units); P = 0.0004], decreased length of hospital stay (median 8 versus 9 days; P = 0.0158) and decreased renal risk (P < 0.0001). Incidence of renal failure, postoperative infection, postoperative thrombosis, prolonged ventilation, total ICU hours and 30-day mortality were not different between the two groups. Vld-rFVIIa for cardiac surgical bleeding was associated with decreased red blood cell transfusion, renal risk and length of hospital stay without increased thromboembolism or mortality when compared to patients who had cardiac surgical bleeding and received standard of care without Factor VIIa.

Evolution of Diagnostic and Treatment Patterns of Cardiac Sarcoidosis.

Cardiac sarcoidosis (CS) may impart substantial morbidity and mortality, and novel imaging modalities are now available to aid in early diagnosis of this clinically silent disease. A better understanding of the clinical experience with CS is important. Twenty-eight patients were diagnosed with the aid of multimodality imaging techniques and were treated by a multidisciplinary team. Demographics, symptomatology, imaging, and therapeutic interventions were compiled from our referral center. In patients with CS, nuclear and MR techniques were often the first studies performed. Echocardiographic findings differed widely. Immunosuppressive therapy and cardiac devices were frequently used. Importantly, isolated CS was not an infrequent finding.

Endovascular Abdominal Aortic Aneurysm Repair.

Most abdominal aortic aneurysms are treated with endovascular repair (EVAR) in current practice. EVAR has lower periprocedural mortality and morbidity than open surgical repair. Aneurysm neck morphology, iliac anatomy, and access vessel anatomy need careful assessment for the successful performance of EVAR. Regular and long-term follow-up with imaging is mandatory after EVAR, and patients who are less likely to comply are less favorable EVAR candidates. Endoleaks are the most frequent complication of EVAR. Most can be managed with transcatheter or endovascular means. Evolving technology and techniques are allowing more patients to be treated with EVAR with better long-term outcomes.

Vascular complications associated with percutaneous left ventricular assist device placement: A 10-year US perspective.

BACKGROUND: Over the last decade, there has been a significant increase in the use of percutaneous left ventricular assist devices(p-LVADs). p-LVADs are being increasingly used during complex coronary interventions and for acute cardiogenic shock. These large bore percutaneous devices have a higher risk of vascular complications. We examined the vascular complication rates from the use of p-LVAD in a national database. METHODS: We conducted a secondary analysis of the National In-patient Sample (NIS) dataset from 2005 till 2015. We used the ICD-9-CM procedure codes 37.68 and 37.62 for p-LVAD placement regardless of indications. We investigated common vascular complications, defining them by the validated ICD 9 CM codes. χ2 test and t test were used for categorical and continuous variables, respectively for comparison. RESULTS: A total of 31,263 p-LVAD placements were identified during the period studied. A majority of patients were male (72.68%) and 64.44% were white. The overall incidence of vascular complications was 13.53%, out of which 56% required surgical treatment. Acute limb thromboembolism and bleeding requiring transfusion accounted for 27.6% and 21.8% of all vascular complications. Occurrence of a vascular complication was associated with significantly higher in-hospital mortality (37.77% vs. 29.95%, p < .001), length of stay (22.7 vs. 12.2 days, p < .001) and cost of hospitalization ($ 161,923 vs. $ 95,547, p < .001). CONCLUSIONS: There is a high incidence of vascular complications with p-LVAD placement including need for vascular surgery. These complications are associated with a higher in-hospital, LOS and hospitalization costs. These findings should be factored into the decision-making for p-LVAD placement.

Characteristics Associated With Mortality in 372 Patients Receiving Low-Dose Recombinant Factor VIIa (rFVIIa) for Cardiac Surgical Bleeding.

OBJECTIVE: Activated recombinant factor VII (rFVIIa) has been used to treat cardiac surgical bleeding in an off-label manner. This observational report analyzes the outcomes with use of a low dose and early administration of rFVIIa for cardiac surgical bleeding. DESIGN: A retrospective, observational study. SETTING: Single-center, tertiary care cardiothoracic surgical setting. PARTICIPANTS: A total of 6,862 patients underwent cardiac surgery from January 2012 to January 2018. Of those, 372 patients received rFVIIa perioperatively. INTERVENTIONS: An institutional policy directed low-dose, incremental aliquots of intravenous rFVIIa (0.5-1 mg). Characteristics and outcomes were compared among patients who survived (n = 328) and patients who died (n = 44). MEASUREMENTS AND MAIN RESULTS: The median dose of rFVIIa was low at 13.29 µg/kg. Higher doses were given to patients who died (15.79 µg/kg v 12.99 µg/kg; p = 0.0133). Patients who died received more blood and component transfusions (median 9 products in those who died v 6 products in survivors; p = 0.0022), although the median transfusion requirement for all patients was 6 units per patient. The rate of reoperation was not different in the 2 groups. Mortality was associated with emergent/urgent surgical procedures (p = 0.0282), type of surgical procedure with aortic procedures being highest risk (p = 0.0014), cardiogenic shock (p = 0.0028), postoperative renal failure (p = 0.0035), postoperative cardiac arrest (p = 0.0006), and ischemic stroke (p = 0.0084). CONCLUSION: Mortality after life-threatening cardiac surgical bleeding treated with rFVIIa was more common in aortic procedures and emergent and urgent surgeries. Lower doses of rFVIIa than previously reported may achieve bleeding cessation because overall blood component transfusions were low in this cohort.

Outcomes following cryoballoon ablation for atrial fibrillation guided by pressure waveform monitoring without the routine use of pulmonary venography.

PURPOSE: Pressure waveform analysis has the potential for facilitated assessment of pulmonary vein occlusion during cryoballoon ablation for atrial fibrillation. Data on clinical outcomes using this method are lacking. We sought to validate through clinical outcomes the use of pressure waveform analysis as the primary method of determining pulmonary vein occlusion during cryoballoon ablation. METHODS: A study was performed of 122 consecutive patients with atrial fibrillation (85% paroxysmal) undergoing cryoballoon ablation from May 2014 through July 2015 at a single institution using pressure waveform analysis as the primary method of assessing pulmonary vein occlusion. RESULTS: Cryoballoon ablation, with additional segmental radiofrequency ablation in 13.7%, resulted in complete pulmonary vein isolation in 100% of patients. The single procedure freedom from recurrence of atrial arrhythmia beyond the initial 3-month post-ablation was 81.2% at a mean follow-up of 237 days. Recurrence of atrial arrhythmia within 3-month post-ablation was 11.1%, and predicted recurrence beyond 3 months. Repeat ablation was performed in 12.0% of patients. CONCLUSIONS: In the largest study to date on this topic and the only study to focus on clinical outcomes, pressure waveform analysis as the primary method of determining pulmonary vein occlusion in cryoballoon ablation of atrial fibrillation resulted in acute and long-term procedural success rates comparable to those reported with use of routine pulmonary venography. Controlled study is needed to confirm these findings and to determine if this technique affects variables such as procedure duration and radiation exposure.