Direct Aortic Access for Transcatheter Aortic Valve Replacement Using a Self-Expanding Device.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) using a self-expanding valve has been shown to be superior to an open operation in high-risk patients. Extensive iliofemoral peripheral vascular disease can prohibit femoral access. In these cases, direct aortic (DA) implantation may be a suitable option. METHODS: The current analysis compared outcomes in patients undergoing TAVR with the self-expanding CoreValve prosthesis (Medtronic, Minneapolis, MN) by direct aortic (DA) access vs iliofemoral (IF) access. Patients treated in the CoreValve US High Risk and Extreme Risk Pivotal Trials and Continued Access Study were included. Propensity score matching was used to account for differences in baseline characteristics between groups. Clinical outcomes were compared at 30 days and 1 year. RESULTS: We identified 394 matched pairs of IF and DA patients. The all-cause mortality rate was significantly higher in the DA group than in the IF group at 30 days (10.9% vs 4.1%, p < 0.001), but this difference was reduced at 1 year (28.1% vs 23.2%, p = 0.063). All-cause mortality or major stroke was significantly higher for DA vs IF access at 30 days (13.5% vs 5.3%, p < 0.001) and at 1 year (30.4% vs 24.2%, p = 0.025). Major/life-threatening bleeding and acute kidney injury were significantly greater in the DA group at 30 days (66.7% vs 35.4% and 19.7% vs 10.0%, respectively, both p < 0.001). CONCLUSIONS: When femoral access is not feasible, DA access allows effective delivery of the valve but incurs an increased risk of death and adverse events, potentially the result of procedural differences.

1-Year Results in Patients Undergoing Transcatheter Aortic Valve Replacement With Failed Surgical Bioprostheses.

OBJECTIVES: This study evaluated the safety and effectiveness of self-expanding transcatheter aortic valve replacement (TAVR) in patients with surgical valve failure (SVF). BACKGROUND: Self-expanding TAVR is superior to medical therapy for patients with severe native aortic valve stenosis at increased surgical risk. METHODS: The CoreValve U.S. Expanded Use Study was a prospective, nonrandomized study that enrolled 233 patients with symptomatic SVF who were deemed unsuitable for reoperation. Patients were treated with self-expanding TAVR and evaluated for 30-day and 1-year outcomes after the procedure. An independent core laboratory was used to evaluate serial echocardiograms for valve hemodynamics and aortic regurgitation. RESULTS: SVF occurred through stenosis (56.4%), regurgitation (22.0%), or a combination (21.6%). A total of 227 patients underwent attempted TAVR and successful TAVR was achieved in 225 (99.1%) patients. Patients were elderly (76.7 ± 10.8 years), had a Society of Thoracic Surgeons Predicted Risk of Mortality score of 9.0 ± 6.7%, and were severely symptomatic (86.8% New York Heart Association functional class III or IV). The all-cause mortality rate was 2.2% at 30 days and 14.6% at 1 year; major stroke rate was 0.4% at 30 days and 1.8% at 1 year. Moderate aortic regurgitation occurred in 3.5% of patients at 30 days and 7.4% of patients at 1 year, with no severe aortic regurgitation. The rate of new permanent pacemaker implantation was 8.1% at 30 days and 11.0% at 1 year. The mean valve gradient was 17.0 ± 8.8 mm Hg at 30 days and 16.6 ± 8.9 mm Hg at 1 year. Factors significantly associated with higher discharge mean aortic gradients were surgical valve size, stenosis as modality of SVF, and presence of surgical valve prosthesis patient mismatch (all p < 0.001). CONCLUSIONS: Self-expanding TAVR in patients with SVF at increased risk for surgery was associated with a low 1-year mortality and major stroke rate, significantly improved aortic valve hemodynamics, and low rates of moderate and no severe residual aortic regurgitation, with improved quality of life.

One-Year Outcomes of Transcatheter Aortic Valve Replacement in Patients With End-Stage Renal Disease.

BACKGROUND: End-stage renal disease (ESRD) poses unique challenges in the treatment of patients with severe aortic stenosis. Although surgical valve replacement in ESRD patients has been associated with increased mortality, the outcomes from transcatheter aortic valve replacement (TAVR) are not clearly defined. METHODS: The CoreValve US Expanded Use Study is a prospective, nonrandomized study of TAVR in extreme-risk patients with comorbidities excluding them from the Pivotal Trial. We report on patients with ESRD. The primary endpoint was a composite of all-cause mortality or major stroke at 1 year. RESULTS: Ninety-six patients with ESRD underwent TAVR with the CoreValve (Medtronic, Minneapolis, MN) and have reached 1-year follow-up. Mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 16.2% ± 8.4%. The rate of all-cause mortality or major stroke at 1 year was 30.3%. The all-cause mortality rate was 5.3% at 30 days and 30.3% at 1 year. The rate at 1 year of any stroke or transient ischemic attack was 2.1%; major vascular injury was 5.2%; and new permanent pacemaker was 26.8%. Valve performance improved postprocedure and remained improved at 1 year (effective orifice area 1.71 cm2, mean gradient 9.33 mm Hg) CONCLUSIONS: Early mortality in patients with ESRD is comparable to previously published data on extreme-risk patients without ESRD, but our data suggest a higher mortality rate at 1 year for ESRD patients, likely due to comorbid conditions. Stroke and major vascular injury are infrequent, and improved valve hemodynamics are maintained at 1 year.

2-Year Outcomes After Iliofemoral Self-Expanding Transcatheter Aortic Valve Replacement in Patients With Severe Aortic Stenosis Deemed Extreme Risk for Surgery.

BACKGROUND: We reported favorable 1-year outcomes in patients unsuitable for surgery who underwent self-expanding transcatheter aortic valve replacement (TAVR) compared with an objective performance goal. Longer-term outcomes in these patients are not known. OBJECTIVES: This study sought to evaluate the 2-year safety and efficacy in patients with severe aortic stenosis (AS) at extreme risk of surgery treated with self-expanding TAVR. METHODS: We performed a prospective, multicenter, controlled, nonrandomized investigation of self-expanding TAVR in patients with severe AS and prohibitive surgical risk. We report the 2-year clinical outcomes in these patients. RESULTS: A total of 489 extreme-risk patients were treated transfemorally with a self-expanding aortic bioprosthesis at 41 centers. The rate of all-cause mortality or major stroke was 38.0% at 2 years (all-cause mortality, 36.5%; major stroke, 5.1%). The rates of all-cause mortality, cardiovascular mortality, and major stroke were 36.6%, 26.2%, and 5.1%, respectively, at 2 years. Between 1 and 2 years, the incremental all-cause mortality, cardiovascular mortality, and major stroke rates were 12.3%, 7.9%, and 0.8%, respectively. Multivariable predictors of all-cause mortality at 2 years included the presence of coronary artery disease and admission from an assisted living center. A Society of Thoracic Surgeons score >15% was also predictive of 2-year all-cause mortality. At 2 years, 94% of patients had New York Heart Association functional class I or II symptoms. The frequency of moderate or severe paravalvular regurgitation (4.3% at 1 year; 4.4% at 2 years) was unchanged between the first and second year. CONCLUSIONS: Patients with severe AS at extreme surgical risk treated with self-expanding TAVR continued to show good clinical outcomes and hemodynamic valve performance at 2 years. The presence of comorbid conditions rather than valve performance affected 2-year outcomes in these patients. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).

Impact of the 80-hour workweek on surgical case exposure within a general surgery residency program.

OBJECTIVE: The objective of this statistical analysis was to test the hypothesis that implementation of the 80-hour workweek restrictions for General Surgery residents at Riverside Methodist Hospital after July 2003 decreased their operative experience relative to surgical residents trained at Riverside before these changes. DESIGN, SETTING, PARTICIPANTS: Data were collected from the Accreditation Council for Graduate Medical Education national database and from Riverside Methodist Hospital's General Surgery Residency records for a sampling of academic years before and after the duty-hour changes in surgical education (July 1, 2003). Current procedural terminology (CPT) surgical procedure codes logged by postgraduate year (PGY) 5 General Surgery residents 15 years before and 5 years after implementation of the 80-hour workweek were compared. The outcome variables "total major cases" and "Chief cases" were compared between 2 study groups defined by the time intervals exclusively before July 2003 ("pre") and inclusively after July 2003 ("post"). Hospital general surgical case volume for the study intervals was also tallied. Statistical analyses included 1- and 2-sided t-tests, nonparametric tests, and t-tests on a 3-parameter logarithmic transformation of the data. RESULTS: Despite an upward trend in total general surgery cases (slope = 25/year, p = 0.005), there was a statistically significant decrease in the operative experience for categorical surgical residents following the 80-hour workweek restrictions. The mean (SD) number of major cases performed by "pre"-restriction residents during their training significantly exceeded that of their "post" cohorts (1395 [326] vs 953 [134], p < 0.001). The training for PGY 5 residents was similarly influenced (345 [81] vs 237 [55], p < .0001). CONCLUSIONS: Despite an increase in the total number of major operative cases available, the volume of cases performed by residents has decreased after implementation of the Accreditation Council for Graduate Medical Education (ACGME) work-hour restrictions. Our data suggest that the impact of the 80-hour workweek has had a detrimental effect on the conventional resident training experience.

Combined distal aortic perfusion and balloon occlusion to facilitate the repair of complex thoracic and thoracoabdominal aortic aneurysms.

We investigated a unique method utilising a Heartport bifurcated arterial cannula and an aortic occlusion balloon to provide both distal perfusion and bloodless, distal arterial exposure during repair of thoracic and thoracoabdominal aortic pathology. Between February 2002 and September 2008, 21 patients underwent thoracic or thoracoabdominal aortic repair with this method. Because of an inability or potential difficulty in achieving distal aortic control secondary to anatomic or technical challenges, a compliant balloon was passed through the accessory arterial channel using fluoroscopic guidance. Adjunctive cerebrospinal drainage was used in all cases. Ballon deployment and satisfactory occlusion was attained in all cases. The overall 30-day mortality rate was 4.75% (1 of 21 patients). Renal failure occurred in one patient (4.75%) and heart failure occurred in two patients (9.5%). Six patients (29%) had pulmonary complications. Transient encephalopathy occurred in two patients (9.5%). Spinal cord neurologic deficit and stroke were avoided in all patients. We recommend the application of this simple method to obtain a bloodless anastomotic field and maintain ongoing distal aortic perfusion in instances where distal control with a clamp is challenging, not feasible or presents the potential for catastrophic intra-operative bleeding.

Evaluation of the complexity of open abdominal aneurysm repair in the era of endovascular stent grafting.

OBJECTIVE: Endovascular repair has proven to be an effective treatment for many abdominal aortic aneurysms (AAA). Aneurysms that require open repair have usually been disqualified from an endovascular approach as a result of a variety of anatomic constraints, which may also make open repair more difficult. Our purpose was to review open AAA repair and assess the complexity of the operative procedure and associated morbidity and mortality data in the era of endovascular stent grafting. METHODS: We retrospectively reviewed the records of 606 patients undergoing elective open AAA repair at a single tertiary care community hospital from January 1, 1996, to December 31, 2004. Patients with ruptured aneurysms and all endovascular repairs were excluded. Patients were grouped into two categories. Group 1 included 301 patients who underwent open repair before the initiation of an endovascular stent grafting program in November 1999. Group 2 included 305 patients who underwent open repair after the initiation of the stent graft program. Operative reports were reviewed to determine the location of the proximal aortic cross clamp, management of the renal vein, associated iliac aneurysmal or occlusive disease, and type of surgical reconstruction. Morbidity, mortality, and disposition data were compared for the two groups and subjected to chi2 analysis. RESULTS: Suprarenal aortic cross-clamp placement was required in 6% of group 1 patients and 20% of group 2 patients (P < .05). Division of the renal vein was necessary in 11% of group 1 patients and 18% of group 2 patients (P < .05). Iliac aneurysms were present in 25% of group 1 patients and 42% of group 2 patients (P < .05). The incidence of associated iliac occlusive disease was 12% in group 1 and 20% in group 2 (P < .05). The type of reconstruction required (aortoaorto, aortoiliac, aortofemoral) was not found to be statistically significant. All major sources of morbidity, including renal insufficiency, myocardial infarction, stroke, and intubation times, were similar between the two groups. The length of stay was 9.2 days in both groups, and 11.3% of group 1 patients and 26% of group 2 patients were discharged to an extended-care facility rather than directly home. The overall mortality rate was 2.0% for patients in group 1 and 3.8% for group 2 patients. This was not a statistically significant difference. CONCLUSIONS: Surgeons performing open repair of AAA in the era of endovascular stent grafting are operating on patients who require more complex repairs, including a greater frequency of suprarenal cross clamping, renal vein division, and management of associated iliac aneurysmal and occlusive disease. Despite this, morbidity and mortality rates are similar to those in patients operated on before the initiation of an endovascular stent grafting program.

The clinical and fiscal impact of endovascular repair of abdominal aortic aneurysms.

PURPOSE: This study analyzed cost, reimbursement, application, and outcome differences between endovascular (ER) and open repair (OR) of abdominal aortic aneurysms (AAA) in a community hospital. METHOD: A total of 187 consecutive elective AAA repairs by both methods (69 ER, 118 OR) performed at a single center between July 2001 and March 2003 were analyzed. Average values in postoperative clinical and fiscal demographics were calculated for this period. RESULTS: The average length of stay was higher for OR than ER (9.38 days versus 1.94 days, P < .001). Significant reductions in operative time (4 hours versus 2.67 hours) and intensive care unit use (100% versus 4.05%) were seen in the ER population. Total hospital costs were slightly higher for OR than ER (21,989 dollars versus 19,668 dollars) despite a considerable difference in cost of the grafts (>11,000 dollars for ER versus <500 dollars for OR). However, hospital charges were much lower for ER than OR (32,660 dollars versus 48,877 dollars), and there was an average loss of 4986 dollars on ER cases versus a profit of 2064 dollars on OR procedures. Thirty-day mortality was not significantly improved in the ER population (1.45% versus 2.54%, P = .05). CONCLUSIONS: Our data suggest that ER offers improvements in hospital convalescence and operating room times but no improvements in fiscal impact or overall morbidity/ mortality rates when similar preoperative medical risks exist.

Challenges associated with the integration of endovascular repair of abdominal aortic aneurysms in a community hospital.

PURPOSE: There has been considerable debate regarding the proper place for endovascular repair (ER) of abdominal aortic aneurysms (AAAs) versus traditional open repair (OR). Our study compared preoperative patient demographics and outcomes for elective, asymptomatic AAA repairs performed at our center over a 33-month period. METHODS: For this study, we selected 342 consecutive elective infrarenal AAA repairs performed between July 1, 2000, and March 31, 2003, at Riverside Methodist Hospital. The patients underwent either ER or OR, depending on patient and surgeon collaborative determinations. Ruptured and symptomatic AAAs were excluded from our study. Preoperative demographics, anesthesia, complications, and discharge status for the 2 groups were analyzed, and statistical analysis was done to determine statistically significant differences. RESULTS: The preoperative status of the ER and OR patient groups were essentially similar. There were only 3 significant differences between the 2 groups: alcohol use was higher for the OR group than for the ER group (12.0% versus 5.2%; P = .04), and the incidence of type II diabetes mellitus and peripheral vascular disease were lower for the OR group compared with the ER group (6.7% versus 13.4% [P = .04] and 18.3% versus 30.6% [P = .008], respectively). The OR group used more general anesthesia than the ER group (99% versus 86%; P < .001) and had more complications, including dysrhythmia (8.65% versus 1.59%; P = .005), ileus (13.94% versus 0.79%; P < .0001), infection (8.17% versus 0.0%; P = .0007), respiratory complications (12.50% versus 1.59%; P = .0003), and renal complications (5.29% versus 0.79%; P = .032). The ER group had a higher rate of wound hematoma (4.76% versus 0.48%; P = .007). ER patients also had significantly less blood loss (379 mL versus 1930 mL; P < .001), a better independent discharge status (P < .0001), a shorter length of stay (1.8 days versus 8.2 days; P < .001), and a lower mortality rate (0.75% versus 3.85%; P = .0954). CONCLUSIONS: From our study we cautiously continue to encourage the consideration of the ER of AAAs in our patient population while being mindful of its limitations.

Oblique groin incision for endovascular repair of abdominal aortic aneurysms.

PURPOSE: Groin incision for access to the femoral artery is necessary for stent graft repair of abdominal aortic aneurysm (AAA). However, lymphatic and infectious complications can occur during wound healing after surgery. A vertical incision traditionally is used, but a new oblique incision technique has the potential to reduce complications. We report our results from AAA stent repairs performed via oblique incisions at our center for a 33-month period. METHODS: Data for 134 consecutive patients undergoing elective stent repair of asymptomatic infrarenal AAA performed by 2 cardiovascular surgeons at a single center from July 1, 2000, to March 31, 2003, were gathered for analysis. Wound complication percentages for infections, paresthesias, sepsis, and seroma were calculated. RESULTS: In 134 patients, a total of 278 incisions were made. Reasons for extra incisions included improving catheter entry angle (5 cases), tunneling for vascular tapes (3 cases), and initial approach too low (2 cases). The percentages were, however, calculated on a per-patient basis. Thirty day analysis revealed a 0% infection rate, 4.7% incidence of paresthesias, 2.38% rate of wound seroma, and 0% wound sepsis rate. CONCLUSION: Because of the nonexistent infection rate and low wound complication rate, our data supports the use of oblique groin incisions for stent repair of asymptomatic infrarenal AAA.