Intercostal Cryo Nerve Block in Minimally Invasive Cardiac Surgery: The Prospective Randomized FROST Trial.

INTRODUCTION: Intercostal cryo nerve block has been shown to enhance pulmonary function recovery and pain management in post-thoracotomy procedures. However, its benefit have never been demonstrated in minimal invasive thoracotomy heart valve surgery (Mini-HVS). The purpose of the study was to determine whether intraoperative intercostal cryo nerve block in conjunction with standard of care (collectively referred to hereafter as CryoNB) provided superior analgesic efficacy in patients undergoing Mini-HVS compared to standard-of-care (SOC). METHODS: FROST was a prospective, 3:1 randomized (CryoNB vs. SOC), multicenter trial in patients undergoing Mini-HVS. The primary endpoint was the 48-h postoperative forced expiratory volume in 1 s (FEV1) result. Secondary endpoints were visual analog scale (VAS) scores for pain at the surgical site and general pain, intensive care unit and hospital length-of-stay, total opioid consumption, and allodynia at 6 months postoperatively. RESULTS: A total of 84 patients were randomized to the two arms of the trial CryoNB (n = 65) and SOC (n = 19). Baseline Society of Thoracic Surgeons Predictive Risk of Mortality (STS PROM) score, ejection fraction, and FEV1 were similar between cohorts. A higher 48-h postoperative FEV1 result was demonstrated in the CryoNB cohort versus the SOC cohort (1.20 ± 0.46 vs. 0.93 ± 0.43 L; P = 0.02, one-sided two-sample t test). Surgical site VAS scores were similar between the CryoNB and SOC cohorts at all postoperative timepoints evaluated, but VAS scores not related to the surgical site were lower in the SOC group at 72, 94, and 120 h postoperatively. The SOC cohort had a 13% higher opioid consumption than the CryoNB cohort. One of 64 CryoNB patients reported allodynia that did not require pain medication at 10 months. CONCLUSIONS: The results of FROST demonstrated that intercostal CryoNB provided enhanced FEV1 score at 48 h postoperatively with optimized analgesic effectiveness versus SOC. Future larger prospective randomized trials are warranted to determine whether intercostal CryoNB has an opioid-sparing effect in patients undergoing Mini-HVS. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02922153.

Transfemoral Transcatheter Aortic Valve Replacement Using Fascia Iliaca Block as an Alternative Approach to Conscious Sedation as Compared to General Anesthesia.

BACKGROUND/PURPOSE: General Anesthesia (GA) and conscious sedation (CS) are anesthetics for transfemoral transcatheter aortic valve replacement (TF-TAVR). We compared TF-TAVR outcomes using a novel anesthetic approach with fascia iliaca block (FIB) plus minimal CS (MCS) versus GA. METHODS: This retrospective propensity-matched study included consecutive TF-TAVR patients from January 2013 to December 2017 and dichotomized into FIB-MCS vs. GA. Data were collected from electronic records, Society of Thoracic Surgery (STS) database, and the Transcatheter Valve Therapies (TVT) Registry. Primary endpoints were operating room (OR) time, intensive care unit (ICU) and hospital length of stay (LOS). Secondary endpoints were 30-day, 1-year mortality, quality of life, 30-day re-hospitalization rate, failure of FIB-MCS, and hospital safety outcomes. RESULTS: A total of 304 TF-TAVR patients; FIB-MCS (n = 219) vs. GA (n = 85). Propensity matched 162 patients; FIB-MCS (n = 108) vs. GA (n = 54). FIB-MCS had shorter OR time (197.6 ±â€¯56.3 vs. 248.2 ±â€¯46.3 min, p < 0.001), ICU (67.8 ±â€¯71.7 vs. 84.9 ±â€¯72.1 h, p = 0.004) and hospital LOS (3.2 ±â€¯3.7 vs. 5.9 ±â€¯3.5 d, p < 0.001). FIB-MCS had lower rate of blood transfusion. FIB-MCA vs. GA 30-day and 1-year mortality were similar in the entire (2.3 vs. 2.4%, p = 1.0; and 8.2 vs. 5.9%, p = 0.49) and matched cohorts (0 vs. 3.7%, p = 0.11 and 7.4 vs. 5.6%, p = 0.75). FIB-MCS were less likely to be re-hospitalized [Odd Ratio: 0.32, CI:0.13-0.76] and 2% to 3% higher KCCQ-12 score. CONCLUSION: TF-TAVR using FIB-MCS is feasible and safe with shorter OR time, ICU and hospital LOS, lower risk of 30-day re-hospitalization, similar 30-day and 1-year mortality with better quality of life at 1-year follow-up.

Single-dose cardioplegia protects myocardium as well as traditional repetitive dosing: A noninferiority randomized study.

OBJECTIVE: The present prospective noninferiority randomized trial was designed to demonstrate the safety and efficacy of a single dose of Custodiol histidine-tryptophan-ketoglutarate compared with repetitive cold-blood cardioplegia. METHODS: From October 2012 to May 2014, 110 patients were randomly assigned to 1 of 2 groups: Group 1 (55 patients) received repetitive cold-blood cardioplegia, and group 2 (55 patients) received single-dose Custodiol histidine-tryptophan-ketoglutarate. Isolated aortic valve replacement, isolated mitral valve replacement, and multivalve procedures represented the most frequent operations, with 39 cases (71%) in group 1 and 49 cases (89%) in group 2. There was no difference in cardiopulmonary bypass time (102 ± 26 minutes vs 99 ± 19 minutes, P = .70) or aortic crossclamp time (77 ± 19 minutes vs 74 ± 17 minutes, P = .33). All patients underwent preoperative electrocardiogram and determination of creatine kinase-MB, troponin I, left ventricular ejection fraction, and regional wall motion. Postoperative cardiac biomarkers were checked at 7, 24, and 48 hours, and an echocardiogram was obtained to check for left ventricular function abnormalities. RESULTS: There was no difference in cardiac biomarkers release between the 2 groups at baseline and 7, 24, and 48 hours postoperatively (creatine kinase, P = .18, troponin P = .23). Left ventricular function was similar between groups preoperatively and at 24 hours after surgery. No death or myocardial infarction was observed in either group. There were no differences in intensive care unit length of stay, incidence of atrial fibrillation, use of inotropes or vasopressors support, time of intubation, or creatinine levels. CONCLUSIONS: A single dose of Custodiol histidine-tryptophan-ketoglutarate cardioplegia is not inferior to repeated cold-blood cardioplegia during elective cardiac surgery.

Effect of cardiorespiratory fitness on short-term morbidity and mortality after coronary artery bypass grafting.

Although preoperative risk assessment for coronary artery bypass grafting (CABG) has been evaluated with multiple predictive models, none have incorporated a low level of cardiorespiratory fitness, which represents one of the strongest predictors of all-cause and cardiovascular mortality in subjects with and without heart disease. The aim of the present study was to evaluate preoperative cardiorespiratory fitness, expressed as METs (1 MET = 3.5 ml O2/kg/min), and short-term morbidity and mortality after CABG. The Society of Thoracic Surgeons database was queried for patients who underwent CABG from January 2002 to December 2010 at Beaumont Health Systems. Electronic medical records were reviewed for peak or symptom-limited exercise testing <90 days before CABG. Peak METs were estimated from the achieved treadmill speed, grade, and duration or the cycle ergometer workload, corrected for body weight. Patients who met eligibility criteria (n = 596) were categorized into 2 groups: those with reduced aerobic capacity (<5 METs [n = 78]) and those achieving ≥5 METs (n = 518). Fisher's exact tests were used to compare preoperative aerobic capacity and short-term postoperative morbidity and mortality between the 2 groups. After adjusting for potential confounding variables, an inverse relation was found between cardiorespiratory fitness and complications after CABG. Specifically, low preoperative cardiorespiratory fitness (<5 METs) was associated with higher operative and 30-day mortality after CABG (p <0.05). In conclusion, these data suggest that preoperative cardiorespiratory fitness provides an independent and additive marker for mortality after CABG.

St Jude Medical Epic porcine bioprosthesis: results of the regulatory evaluation.

BACKGROUND: The St Jude Medical Epic heart valve (St Jude Medical, Inc, St Paul, Minn) is a tricomposite glutaraldehyde-preserved porcine bioprosthesis. The St Jude Medical Biocor porcine bioprosthesis is the precursor valve to the St Jude Medical Epic valve. The Epic valve is identical to the Biocor valve except that it is treated with Linx AC ethanol-based calcium mitigation therapy. METHODS: The St Jude Medical Epic valve was implanted in 761 patients (mean age 73.9 ± 9.2 years) between 2003 and 2006 in the US Food and Drug Administration regulatory study in 22 investigational centers. The position distribution was 557 aortic valve replacements, 175 mitral valve replacements, and 29 double valve replacements. Concomitant coronary artery bypass grafting was performed in 50.8% of patients undergoing aortic valve replacement and 36.6% of those undergoing mitral valve replacement. RESULTS: The early mortality was 3.6% in aortic and 2.3% in mitral valve replacement. The follow-up was 1675.5 patient-years with a mean of 2.2 ± 1.2 years/patient. Late mortality was 5.2%/patient-year in aortic and 6.6%/patient-year in mitral valve replacement. The late major thromboembolism rate was 0.98%/patient-year for aortic and 2.6%/patient-year for mitral valve replacement. There were 19 reoperations, including 2 for structural valve deterioration, 1 for thrombosis, 9 for nonstructural dysfunction, and 7 for prosthetic valve endocarditis. The actuarial freedom from reoperation owing to structural valve deterioration for aortic valve replacement at 4 years for age 60 years or less was 93.3% ± 6.4%; for ages 61 to 70 years, 98.1% ± 1.9%; and for older than 70 years, 100% (P = .0006 > 70 vs ≤ 60 years). There were no events of structural deterioration with mitral valve replacement. The actuarial freedom from major thromboembolism for all patients at 4 years was 93.6% ± 1.0%. The 2 cases of structural valve deterioration occurred in aortic valves that became perforated without calcification causing aortic regurgitation. CONCLUSIONS: The performance of the St Jude Medical Epic porcine bioprosthesis is satisfactory at 4 years for both aortic and mitral valve replacement. This study establishes the early clinical performance including durability of this porcine bioprosthesis.

Left ventricular myxoma resection with minimally invasive mitral valve reconstruction.

Ventricular myxomas are rare, accounting for less than 5% of all benign cardiac tumors. Although histologically benign, myxomas can be a source of significant morbidity and mortality. The case is presented of a left ventricular myxoma involving the posterior papillary muscle that was resected using a minimally invasive transmitral approach. A radical mitral valve reconstruction was performed, including the replacement of two chordae tendineae, annuloplasty and valvuloplasty, resulting in excellent postoperative mitral valve function. Precise preoperative imaging and surgical planning are necessary to achieve adequate tumor margins and to minimize the likelihood of recurrence.

Coronary artery bypass grafting with a minimized cardiopulmonary bypass circuit: a prospective, randomized trial.

OBJECTIVE: The study was designed to determine differences in blood loss and transfusion associated with a minimized cardiopulmonary bypass circuit versus a standard bypass circuit. METHODS: From February 2005 through April 2006, 199 patients were randomized to undergo coronary artery bypass grafting with a standard cardiopulmonary bypass circuit (Medtronic, Inc., Minneapolis, Minn) or a minimized bypass circuit, the Medtronic Resting Heart Circuit. Laboratory perimeters (hemoglobin and platelet count), were measured at baseline, after initiation of cardiopulmonary bypass, and on intensive care unit admission. Lowest values recorded were noted. Blood administration was controlled by study-specific protocol orders, (transfusion for hemoglobin <8mg%). Patient demographic data were retrieved from the Society of Thoracic Surgeons database. Blood product administration was recorded during hospital admission, and chest tube drainage as total output collected from operating room to discontinuation. Continuous variables were tested with a Wilcoxin rank test, and categoric variables with X(2) and Fisher's exact tests. RESULTS: Hematocrit, equivalent at baseline, was higher in minimized circuit cohort at lowest point during cariopulmonary bypass (31.5% +/- 3.9% vs. 25.5% +/- 3.7%), after protamine (31.6% +/- 3.9% vs 29.2% +/- 3.7%), and on intensive care unit arrival (35.2% +/- 4.1% vs 31.8% +/- 3.5%, P < .001). Similarly, platelet count was higher in minimized circuit group on intensive care unit arrival, as was lowest platelet count recorded (170 x 10(3) +/- 48 cells/mm(3) vs 107 x 10(3) +/- 28 cells/mm(3), P < .0001). Time to extubation was shorter in minimized circuit group (848 +/- 737 minutes vs. 526 +/- 282 minutes, (P < .01), and total chest tube drainage was lower (1124 +/- 647 mL vs. 506 +/- 214 mL, P < .01). Fewer red blood cells (148 vs 19 units) were given in minimized circuit group (P < .0001). CONCLUSIONS: A minimized cardiopulmonary bypass circuit provides less hemodilution, platelet consumption, chest tube output and lower post-operative blood loss than standard cardiopulmonary bypass. Red blood cell usage was also less. All differences are advantageous.

Hemodynamics and early clinical performance of the St. Jude Medical Regent mechanical aortic valve.

BACKGROUND: The St. Jude Medical Regent valve is the next-generation bileaflet aortic prosthesis, modified from the currently marketed St. Jude Medical mechanical valve to achieve a larger geometric orifice without changing the existing design of the pivot mechanism or blood-contact surface areas. The present study reports the hemodynamic and early clinical results of an ongoing multicenter trial investigating the performance of the Regent valve. METHODS: Between July 1998 and July 2001, 361 patients at 17 centers in North America and Europe underwent implantation of a Regent mechanical aortic valve prosthesis. Clinical status was prospectively recorded, and echocardiography with Doppler was performed at discharge and at 2 months, 6 months, 1 year, and 2 years after operation. RESULTS: Follow-up to date is 300 patient-years (average, 0.8 +/- 0.7 years per patient; range, 0.0 to 2.7 years). There were low rates of clinical adverse events. Mean gradient at 6 months was 9.7 +/- 5.3 mm Hg, 7.6 +/- 5.2 mm Hg, 6.3 +/- 3.7 mm Hg, 5.8 +/- 3.4 mm Hg, and 4.0 +/- 2.6 mm Hg, respectively, for 19-mm, 21-mm, 23-mm, 25-mm, and 27-mm valves; effective orifice area was 1.6 +/- 0.4 cm2, 2.0 +/- 0.7 cm2, 2.2 +/- 0.9 cm2, 2.5 +/- 0.9 cm2, and 3.6 +/- 1.3 cm2, respectively. Indexed effective orifice area was equal to or greater than 1.0 cm2/m2 for all valve sizes. Left ventricular mass index decreased significantly between early postoperative (165.9 +/- 57.1 g/m2) and 6-month follow-up (137.9 +/- 41.0 g/m2; delta = -28.0 +/- 49.1 g/m2; p < 0.0001). CONCLUSIONS: The St. Jude Medical Regent aortic valve has excellent hemodynamics and early clinical results, with rapid and significant left ventricular mass regression. Long-term clinical assessment is ongoing.