Multicenter experience with valve-in-valve transcatheter aortic valve replacement compared with primary, native valve transcatheter aortic valve replacement.

BACKGROUND: Valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) offers an alternative to reoperative surgical aortic valve replacement. The short- and intermediate-term outcomes after ViV TAVR in the real world are not entirely clear. PATIENTS AND METHODS: A multicenter, retrospective analysis of a consecutive series of 121 ViV TAVR patients and 2200 patients undergoing primary native valve TAVR from 2012 to 2017 at six medical centers. The main outcome measures were in-hospital mortality, 30-day mortality, stroke, myocardial infarction, acute kidney injury, and pacemaker implantation. RESULTS: ViV patients were more likely male, younger, prior coronary artery bypass graft, "hostile chest," and urgent. 30% of the patients had Society of Thoracic Surgeons risk score <4%, 36.3% were 4%-8% and 33.8% were >8%. In both groups many patients had concomitant coronary artery disease. Median time to prosthetic failure was 9.6 years (interquartile range: 5.5-13.5 years). 82% of failed surgical valves were size 21, 23, or 25 mm. Access was 91% femoral. After ViV, 87% had none or trivial aortic regurgitation. Mean gradients were <20 mmHg in 54.6%, 20-29 mmHg in 30.6%, 30-39 mmHg in 8.3% and ≥40 mmHg in 5.87%. Median length of stay was 4 days. In-hospital mortality was 0%. 30-day mortality was 0% in ViV and 3.7% in native TAVR. There was no difference in in-hospital mortality, postprocedure myocardial infarction, stroke, or acute kidney injury. CONCLUSION: Compared to native TAVR, ViV TAVR has similar peri-procedural morbidity with relatively high postprocedure mean gradients. A multidisciplinary approach will help ensure patients receive the ideal therapy in the setting of structural bioprosthetic valve degeneration.

Outcomes of Innominate Artery Revascularization Through Endovascular, Hybrid, or Open Approach.

BACKGROUND: Atherosclerotic disease of the innominate artery (IA) is rare and can lead to cerebral, upper extremity, and vertebral steal symptoms. Nonocclusive lesions can be treated with endovascular interventions, often with a hybrid approach while performing a right carotid endarterectomy (RCEA). Calcified IA lesions have a high risk of embolization to bilateral cerebral hemispheres. Occlusive lesions may require treatment through a median sternotomy and bypass. The purpose of our study is to review our short-term and long-term outcomes of IA revascularization. METHODS: Our operative database was used to identify patients who underwent IA revascularization between January 1998 and December 2018. Patients who underwent innominate artery stenting (IAS), combined with RCEA and IAS as well as aortoinnominate bypass (AIB), were identified. Our primary end points were freedom from neurologic event, all-cause mortality, and need for reintervention. RESULTS: Thirty-three patients (18 females [55%]) who underwent IA revascularization were identified. Average age was 67 ± 8 years, and mean clinical follow-up was 51 ± 21 months. Most patients (30 [91%]) were on a statin and antiplatelet therapy. Twenty-one patients (64%) were symptomatic. Twelve patients (36%) were asymptomatic and underwent combined RCEA with retrograde IAS for critical right carotid stenosis and IA stenosis. Preoperative imaging included a carotid duplex and computed tomography angiography. Eighteen patients (55%) underwent RCEA + IAS, 11 patients (33%) underwent isolated IAS, and 4 patients (12%) underwent AIB. In our attempt to protect bilateral hemispheres during IAS for heavily calcified lesions, we used right common carotid artery (CCA) clamping although open exposure and left CCA embolic protection filter was placed through transfemoral approach. Patients who underwent AIB had chronic heavily calcified IA occlusions or occluded IA stents with failed endovascular interventions. Perioperative stroke rate was 3%, involving 1 patient who developed reperfusion syndrome after RCEA + IAS. Perioperative mortality was 0%. Long-term stroke rate was 0%, and long-term mortality was 15% (5 of 33) because of cardiac disease. Overall restenosis rate was 9%, involving 3 patients who required secondary interventions for IA in-stent restenosis. CONCLUSIONS: IA interventions through a hybrid approach or an open approach are safe, with acceptable perioperative stroke and mortality rates. Long-term patency of these interventions is acceptable. Bilateral cerebral embolic protection can be accomplished by clamping the right CCA through an open exposure and placing a filter in the left CCA through a transfemoral approach. Patients undergoing IAS appear to have a higher rate of restenosis compared with AIB, and therefore, close follow-up with noninvasive imaging is recommended.

The Incidence and Consequence of Prosthesis-Patient Mismatch After Surgical Aortic Valve Replacement.

BACKGROUND: The goal of this study was to determine the relationship of prosthesis-patient mismatch (PPM) with long-term survival and to assess whether growing concern about PPM has resulted in a decreased incidence over time. METHODS: Using The Society of Thoracic Surgeons Adult Cardiac Surgery Database, we identified 59,779 patients ≥65 years old who underwent isolated surgical aortic valve replacement (AVR) between 2004 and 2014. The degree of PPM was calculated using literature-derived effective orifice areas for commonly used valves. Outcomes to 10 years were stratified by degree of PPM. RESULTS: The distribution of PPM was as follows: 35%, none (n = 21,053); 54%, moderate (n = 32,243); and 11%, severe (n = 6,483). Compared with patients with no PPM, patients with moderate or severe PPM had a significantly increased risk of readmission for heart failure (hazard ratio [HR], 1.15; 95% confidence interval [CI], 1.09 to 1.21; HR, 1.37; 95% CI, 1.26 to 1.48) and redo AVR (HR, 1.41; 95% CI, 1.13 to 1.77; HR, 2.68; 95% CI, 2.01 to 3.56) for moderate or severe PPM, respectively. Survival was significantly worse for any degree of PPM (moderate to none: HR, 1.08; 95% CI, 1.05 to 1.12; severe to none: HR, 1.32; 95% CI, 1.25 to 1.39), with 10-year adjusted survival rates of 46%, 43%, and 35% for none, moderate, and severe, respectively (p < 0.001). The incidence of severe PPM decreased by 55% over the study period, from 13.8% in 2004 to 6.2% in 2014. CONCLUSIONS: Any degree of PPM significantly decreased long-term survival and increased readmission rates for both heart failure and reoperation for AVR. Temporal trends show a significant decrease in the incidence of PPM over the past decade.

Coronary Revascularization With Single Versus Bilateral Mammary Arteries: Is It Time to Change?

BACKGROUND: Arterial conduits are preferred to venous conduits for coronary artery bypass grafting because of longer patency. A single internal mammary artery (SIMA) is used routinely. Bilateral internal mammary arteries (BIMA) are used less frequently. We sought to determine whether BIMA were superior to SIMA. METHODS: From our regional registry of consecutive open heart operations, we identified 47,984 patients who underwent isolated coronary artery bypass grafting from 1992 to 2014. Of the 1,482 BIMA patients, 1,297 were propensity matched to a cohort of SIMA patients. Short-term outcomes were compared using standard statistical techniques. Long-term survival was compared using Kaplan-Meier estimators and compared using a log-rank test. RESULTS: BIMA patients were younger and had fewer comorbid conditions than SIMA patients. After propensity weighting, BIMA and SIMA patients were well matched. There was no difference in in-hospital outcomes for BIMA versus SIMA patients for mortality (1.2% [n = 15] vs 0.8% [n = 10], p = 0.315), stroke (0.7% [n = 9] vs 0.7% [n = 9), p = 1.000), bleeding (2.2% [n = 28] vs 2.8% [n = 36], p = 0.311), or mediastinitis (0.8% [n = 10] vs 0.9% [n = 12], p = 0.667). The median follow-up was 12 years. Survival was better for BIMA than SIMA (adjusted hazard ratio, 0.79; 95% confidence interval, 0.69 to 0.91; p < 0.001). Survival curves began to separate after 5 years. At 15 years, the absolute difference in survival was 8.4%. CONCLUSIONS: In a large regional experience, BIMA is associated with no upfront risk of adverse events and improved long-term survival compared with SIMA. Our results indicate that BIMA conduits should be considered more frequently during coronary artery bypass grafting due to their demonstrated survival advantage.

Does Use of Bilateral Internal Mammary Artery Grafting Reduce Long-Term Risk of Repeat Coronary Revascularization? A Multicenter Analysis.

BACKGROUND: Although previous studies have demonstrated that patients receiving bilateral internal mammary artery (BIMA) conduits during coronary artery bypass grafting have better long-term survival than those receiving a single internal mammary artery (SIMA), data on risk of repeat revascularization are more limited. In this analysis, we compare the timing, frequency, and type of repeat coronary revascularization among patients receiving BIMA and SIMA. METHODS: We conducted a multicenter, retrospective analysis of 47 984 consecutive coronary artery bypass grafting surgeries performed from 1992 to 2014 among 7 medical centers reporting to a prospectively maintained clinical registry. Among the study population, 1482 coronary artery bypass grafting surgeries with BIMA were identified, and 1297 patients receiving BIMA were propensity-matched to 1297 patients receiving SIMA. The primary end point was freedom from repeat coronary revascularization. RESULTS: The median duration of follow-up was 13.2 (IQR, 7.4-17.7) years. Patients were well matched by age, body mass index, major comorbidities, and cardiac function. There was a higher freedom from repeat revascularization among patients receiving BIMA than among patients receiving SIMA (hazard ratio [HR], 0.78 [95% CI, 0.65-0.94]; P=0.009). Among the matched cohort, 19.4% (n=252) of patients receiving SIMA underwent repeat revascularization, whereas this frequency was 15.1% (n=196) among patients receiving BIMA (P=0.004). The majority of repeat revascularization procedures were percutaneous coronary interventions (94.2%), and this did not differ between groups (P=0.274). Groups also did not differ in the ratio of native versus graft vessel percutaneous coronary intervention (P=0.899), or regarding percutaneous coronary intervention target vessels; the most common targets in both groups were the right coronary (P=0.133) and circumflex arteries (P=0.093). In comparison with SIMA, BIMA grafting was associated with a reduction in all-cause mortality at 12 years of follow-up (HR, 0.79 [95% CI, 0.69-0.91]; P=0.001), and there was no difference in in-hospital morbidity. CONCLUSIONS: BIMA grafting was associated with a reduced risk of repeat revascularization and an improvement in long-term survival and should be considered more frequently during coronary artery bypass grafting.

Effect of preoperative pulmonary hypertension on outcomes in patients with severe aortic stenosis following surgical aortic valve replacement.

Pulmonary hypertension (PH) is prevalent in patients with aortic stenosis (AS); however, previous studies have demonstrated inconsistent results regarding the association of PH with adverse outcomes after aortic valve replacement (AVR). The goal of this study was to evaluate the effects of preoperative PH on outcomes after AVR. We performed a regional prospective cohort study using the Northern New England Cardiovascular Disease Study Group database to identify 1,116 consecutive patients from 2005 to 2010 who underwent AVR ± coronary artery bypass grafting for severe AS with a preoperative assessment of pulmonary pressures by right-sided cardiac catheterization. PH was defined as a mean pulmonary artery pressure of ≥25 mm Hg, with severity based on the pulmonary artery systolic pressure-mild, 35 to 44 mm Hg; moderate, 45 to 59 mm Hg; and severe, ≥60 mm Hg. We found that PH was present in 536 patients (48%). Postoperative acute kidney injury, low-output heart failure, and in-hospital mortality increased with worsening severity of PH. In multivariate logistic regression, severe PH was independently associated with postoperative acute kidney injury (adjusted odds ratio 4.1, 95% confidence interval [CI] 1.7 to 10, p = 0.002) and in-hospital mortality (adjusted odds ratio 6.9, 95% CI 2.5 to 19.1, p <0.001). There was a significant association between PH and decreased 5-year survival (adjusted log-rank p value = 0.006), with severe PH being associated with the poorest survival (adjusted hazard ratio 2.4, 95% CI 1.3 to 4.2, p = 0.003). In conclusion, severe PH in patients with severe AS is associated with increased rates of in-hospital adverse events and decreased 5-year survival after AVR.

Impact of preoperative left ventricular ejection fraction on long-term survival after aortic valve replacement for aortic stenosis.

BACKGROUND: The survival of patients who undergo aortic valve replacement (AVR) for severe aortic stenosis with reduced preoperative ejection fractions (EFs) is not well described in the literature. METHODS AND RESULTS: Patients undergoing AVR for severe aortic stenosis were analyzed using the Northern New England Cardiovascular Disease Study Group surgical registry. Patients were stratified by preoperative EF (≥50%, 40%-49%, and <40%) and concomitant coronary artery bypass grafting. Crude and adjusted survival across strata of EF was estimated for patients up to 8 years beyond their index admission. A total of 5277 patients underwent AVR for severe aortic stenosis between 1992 and 2008. There were 727 (14%) patients with preoperative EF <40%. Preoperative EF had minimal effect on postoperative morbidity. There was no difference in 30-day mortality across EF strata among the isolated AVR cohort. Preserved EF conferred 30-day survival benefit among the AVR+coronary artery bypass grafting population (EF≥50%, 96%; EF<40%, 91%; P=0.003). Patients with preserved EF had significantly improved 6-month and 8-year survival compared with their reduced EF counterparts. CONCLUSIONS: Survival after AVR or AVR+coronary artery bypass grafting was most favorable among patients with preoperative preserved EF. However, patients with mild to moderately depressed EF experienced a substantial survival benefit compared with the natural history of medically treated patients. Furthermore, minor reductions of EF carried equivalent increased risk to those with more compromised function suggesting patients are best served when an AVR is performed before even minor reductions in myocardial function.

Limited blood transfusion does not impact survival in octogenarians undergoing cardiac operations.

BACKGROUND: We previously reported that transfusion of 1 to 2 units of red blood cells (RBCs) confers a 16% increased hazard of late death after cardiac surgical treatment. We explored whether a similar effect existed among octogenarians. METHODS: We enrolled 17,026 consecutive adult patients undergoing cardiac operations from 2001 to 2008 in northern New England. Patients receiving more than 2 units of RBCs or undergoing emergency operations were excluded. Early (to 6 months) and late (to 3 years, among those surviving longer than 6 months) survival was confirmed using the Social Security Death Index. We estimated the relationship between RBCs and survival, and any interaction by age (<80 years versus ≥80 years) or procedure. We calculated the adjusted hazard ratio (HR), and plotted adjusted survival curves. RESULTS: Patients receiving RBCs had more comorbidities irrespective of age. Patients 80 years of age or older underwent transfusion more often than patients younger than 80 years (51% versus 30%; p<0.001). There was no evidence of an interaction by age or procedure (p>0.05). Among patients younger than 80 years, RBCs significantly increased a patient's risk of early death [HR, 2.03; 95% confidence interval [CI], 1.47, 2.80] but not late death 1.21 (95%CI, 0.88, 1.67). RBCs did not increase the risk of early [HR, 1.47; 95% CI, 0.84, 2.56] or late (HR, 0.92 95% CI, 0.50, 1.69) death in patients 80 years or older. CONCLUSIONS: Octogenarians receive RBCs more often than do younger patients. Although transfusion of 1 to 2 units of RBCs increases the risk of early death in patients younger than 80 years, this effect was not present among octogenarians. There was no significant effect of RBCs in late death in either age group.

Application of total care time and payment per unit time model for physician reimbursement for common general surgery operations.

BACKGROUND: The relative value unit system relies on subjective measures of physician input in the care of patients. A payment per unit time model incorporates surgeon reimbursement to the total care time spent in the operating room, postoperative in-house, and clinic time to define payment per unit time. We aimed to compare common general surgery operations by using the total care time and payment per unit time method in order to demonstrate a more objective measurement for physician reimbursement. STUDY DESIGN: Average total physician payment per case was obtained for 5 outpatient operations and 4 inpatient operations in general surgery. Total care time was defined as the sum of operative time, 30 minutes per hospital day, and 30 minutes per office visit for each operation. Payment per unit time was calculated by dividing the physician reimbursement per case by the total care time. RESULTS: Total care time, physician payment per case, and payment per unit time for each type of operation demonstrated that an average payment per time spent for inpatient operations was $455.73 and slightly more at $467.51 for outpatient operations. Partial colectomy with primary anastomosis had the longest total care time (8.98 hours) and the least payment per unit time ($188.52). Laparoscopic gastric bypass had the highest payment per time ($707.30). CONCLUSIONS: The total care time and payment per unit time method can be used as an adjunct to compare reimbursement among different operations on an institutional level as well as on a national level. Although many operations have similar payment trends based on time spent by the surgeon, payment differences using this methodology are seen and may be in need of further review.

Off-pump coronary artery bypass grafting: Anno 2011.

Since 1998, a large body of literature regarding off-pump coronary bypass surgery has been published, although varying techniques and outcomes likely have led to its inconsistent application. One approach has been developed and standardized at the University Hospitals Leuven, Campus Gasthuisberg, Leuven, Belgium. This approach is straightforward and can be replicated without need for conversion toward cardiopulmonary bypass. The patient is 'conditioned' before and during the procedure. Both mammary arteries are harvested through a standard median sternotomy. The anterior surface of the heart is exposed with a horizontal line of left-sided pericardial stitches, just above the level of the heart. The anterior coronary vessels are anastomosed after routine shunting. The lateral and inferior aspects of the heart are exposed without deforming the atrio-ventricular axis. This is performed in a stepwise manner. The first step is anchoring a sling into the posterior pericardium under the roof of the left atrium. Second, this sling is gradually pulled upwards, supporting the heart as a cradle. Once the heart is exposed towards the zenith, an apical suction device stabilizes, reformats and exposes the ventricle. The lateral and inferior walls are then revascularized. As a strict no-touch aorta technique is used, free grafts are anastomosed to in-situ arterial grafts.

Perioperative stroke and long-term survival after coronary bypass graft surgery.

BACKGROUND: Stroke is a devastating complication of coronary artery bypass graft (CABG) surgery. In-hospital outcomes have been described, yet the long-term effect of stroke on mortality following CABG surgery has not been well studied. METHODS: We examined the survival of 35,733 consecutive patients undergoing isolated CABG surgery in northern New England from 1992 through 2001. Stroke was defined as a new fixed neurologic defect that persisted at least 24 hours after surgery. Patient records were linked to the National Death Index to assess mortality. There were 147,931 person years of follow-up and 5,705 deaths. Cox proportional hazard regression was used to calculate the adjusted hazard ratios (HR) and 95% confidence intervals (95% CI). We identified the 5-year survival stratified by primary stroke mechanism, the patient's functional impact, and discharge location among a subset of patients who had strokes between 1992 and 2000. RESULTS: Perioperative stroke occurred in 575 patients (1.61%). Patients who had strokes had more comorbidities. After adjustments for differences in baseline patient and clinical characteristics, patients who had perioperative stroke were at a significantly increased risk for death (HR, 3.20; 95% CI, 2.80 to 3.66; p < 0.0001). Survival for patients with stroke at 1, 5, and 10 years was 83.0%, 58.7%, and 26.9%, respectively. Five-year survival decreased among patients who had major functional limitations before discharge, among those who had hypoperfusion strokes, and among patients who were discharged to locations other than home or rehabilitation facilities. CONCLUSIONS: Perioperative stroke is associated with a very substantial increased risk of postoperative death among CABG surgery patients. The greatest risk of death was noted within the first year after surgery. Survival after 1 year approximates that of patients who did not suffer a stroke.