Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement.

BACKGROUND: There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk. METHODS: We enrolled 2032 intermediate-risk patients with severe, symptomatic aortic stenosis at 57 centers. Patients were stratified according to intended transfemoral or transthoracic access (76.3% and 23.7%, respectively) and were randomly assigned to undergo either TAVR or surgical replacement. Clinical, echocardiographic, and health-status outcomes were followed for 5 years. The primary end point was death from any cause or disabling stroke. RESULTS: At 5 years, there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group and the surgery group (47.9% and 43.4%, respectively; hazard ratio, 1.09; 95% confidence interval [CI], 0.95 to 1.25; P = 0.21). Results were similar for the transfemoral-access cohort (44.5% and 42.0%, respectively; hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or disabling stroke was higher after TAVR than after surgery in the transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI, 1.02 to 1.71). At 5 years, more patients in the TAVR group than in the surgery group had at least mild paravalvular aortic regurgitation (33.3% vs. 6.3%). Repeat hospitalizations were more frequent after TAVR than after surgery (33.3% vs. 25.2%), as were aortic-valve reinterventions (3.2% vs. 0.8%). Improvement in health status at 5 years was similar for TAVR and surgery. CONCLUSIONS: Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.).

Transcatheter aortic-valve replacement for inoperable severe aortic stenosis.

BACKGROUND: Transcatheter aortic-valve replacement (TAVR) is the recommended therapy for patients with severe aortic stenosis who are not suitable candidates for surgery. The outcomes beyond 1 year in such patients are not known. METHODS: We randomly assigned patients to transfemoral TAVR or to standard therapy (which often included balloon aortic valvuloplasty). Data on 2-year outcomes were analyzed. RESULTS: A total of 358 patients underwent randomization at 21 centers. The rates of death at 2 years were 43.3% in the TAVR group and 68.0% in the standard-therapy group (P<0.001), and the corresponding rates of cardiac death were 31.0% and 62.4% (P<0.001). The survival advantage associated with TAVR that was seen at 1 year remained significant among patients who survived beyond the first year (hazard ratio, 0.58; 95% confidence interval [CI], 0.36 to 0.92; P=0.02 with the use of the log-rank test). The rate of stroke was higher after TAVR than with standard therapy (13.8% vs. 5.5%, P=0.01), owing, in the first 30 days, to the occurrence of more ischemic events in the TAVR group (6.7% vs. 1.7%, P=0.02) and, beyond 30 days, to the occurrence of more hemorrhagic strokes in the TAVR group (2.2% vs. 0.6%, P=0.16). At 2 years, the rate of rehospitalization was 35.0% in the TAVR group and 72.5% in the standard-therapy group (P<0.001). TAVR, as compared with standard therapy, was also associated with improved functional status (P<0.001). The data suggest that the mortality benefit after TAVR may be limited to patients who do not have extensive coexisting conditions. Echocardiographic analysis showed a sustained increase in aortic-valve area and a decrease in aortic-valve gradient, with no worsening of paravalvular aortic regurgitation. CONCLUSIONS: Among appropriately selected patients with severe aortic stenosis who were not suitable candidates for surgery, TAVR reduced the rates of death and hospitalization, with a decrease in symptoms and an improvement in valve hemodynamics that were sustained at 2 years of follow-up. The presence of extensive coexisting conditions may attenuate the survival benefit of TAVR. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).

Two-year outcomes after transcatheter or surgical aortic-valve replacement.

BACKGROUND: The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that among high-risk patients with aortic stenosis, the 1-year survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical replacement. However, longer-term follow-up is necessary to determine whether TAVR has prolonged benefits. METHODS: At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either surgical aortic-valve replacement or TAVR. All patients were followed for at least 2 years, with assessment of clinical outcomes and echocardiographic evaluation. RESULTS: The rates of death from any cause were similar in the TAVR and surgery groups (hazard ratio with TAVR, 0.90; 95% confidence interval [CI], 0.71 to 1.15; P=0.41) and at 2 years (Kaplan-Meier analysis) were 33.9% in the TAVR group and 35.0% in the surgery group (P=0.78). The frequency of all strokes during follow-up did not differ significantly between the two groups (hazard ratio, 1.22; 95% CI, 0.67 to 2.23; P=0.52). At 30 days, strokes were more frequent with TAVR than with surgical replacement (4.6% vs. 2.4%, P=0.12); subsequently, there were 8 additional strokes in the TAVR group and 12 in the surgery group. Improvement in valve areas was similar with TAVR and surgical replacement and was maintained for 2 years. Paravalvular regurgitation was more frequent after TAVR (P<0.001), and even mild paravalvular regurgitation was associated with increased late mortality (P<0.001). CONCLUSIONS: A 2-year follow-up of patients in the PARTNER trial supports TAVR as an alternative to surgery in high-risk patients. The two treatments were similar with respect to mortality, reduction in symptoms, and improved valve hemodynamics, but paravalvular regurgitation was more frequent after TAVR and was associated with increased late mortality. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).

Clinical implications of new-onset left bundle branch block after transcatheter aortic valve replacement: analysis of the PARTNER experience.

AIMS: Cardiac conduction disturbances, including a left bundle branch block (LBBB), occur frequently following transcatheter aortic valve replacement (TAVR) and may be associated with adverse clinical events. This analysis examines the incidence and implications of new onset, persistent LBBB in patients undergoing TAVR with a balloon-expandable valve. METHODS AND RESULTS: Patients undergoing TAVR in the Placement of Aortic Transcatheter Valves (PARTNER) trial and continued access registries with baseline and discharge/7-day electrocardiograms were included. Prior permanent pacemaker implantation (PPI) and baseline intraventricular conduction abnormalities were exclusion criteria. Predictors of new LBBB were identified and outcomes compared between patients with and without new LBBB. New LBBB occurred in 121 of 1151 (10.5%) patients and persisted in more than half at 6 months to 1 year. The only predictor of new LBBB was prior coronary artery bypass grafting. New LBBB was not associated with significant differences in 1-year mortality, cardiovascular mortality, repeat hospitalization, stroke, or myocardial infarction. However, it was associated with increased PPI during hospitalization (8.3 vs 2.8%, P = 0.005) and from discharge to 1 year (4.7 vs. 1.5%, P = 0.01). The ejection fraction failed to improve after TAVR in patients with new LBBB and remained lower at 6 months to 1 year (52.8 vs. 58.1%, P < 0.001). CONCLUSION: Persistent, new-onset LBBB occurred in 10.5% of patients without intraventricular baseline conduction who underwent TAVR in the PARTNER experience. New LBBB was not associated with death, repeat hospitalization, stroke, or myocardial infarction at 1 year, but was associated with a higher rate of PPI and failure of left ventricular ejection fraction to improve.

Midterm outcomes of aortic valve replacement using a rapid-deployment valve for aortic stenosis: TRANSFORM trial.

Background: The use of rapid-deployment valves (RDVs) has been shown to reduce the operative time for surgical aortic valve replacement (AVR). Long-term core laboratory-adjudicated data are scarce, however. Here we report final 7-year data on RDV use. Methods: TRANSFORM was a prospective, nonrandomized, multicenter, single-arm trial implanting a stented bovine pericardial valve with an incorporated balloon-expandable sealing frame. A prior published 1-year analysis included 839 patients from 29 centers. An additional 46 patients were enrolled and implanted, for a total of 885 patients. Annual clinical and core laboratory-adjudicated echocardiographic outcomes were collected through 8 years. Primary endpoints were structural valve deterioration (SVD), all-cause reintervention, all-cause valve explantation, and all-cause mortality. Secondary endpoints included hemodynamic performance assessed by echocardiography. The mean duration of follow-up was 5.0 ± 2.0 years. Results: The mean patient age was 73.3 ± 8.2 years. Isolated AVR was performed in 62.1% of the patients, and AVR with concomitant procedures was performed in 37.9%. Freedom from all-cause mortality at 7 years was 76.0% for isolated AVR and 68.2% for concomitant AVR. Freedom from SVD, all-cause reintervention, and valve explantation at 7 years was 97.5%, 95.7%, and 97.8%, respectively. The mean gradient and effective orifice area at 7 years were 11.1 ± 5.3 mm Hg and 1.6 ± 0.3 cm2, respectively. Paravalvular leak at 7 years was none/trace in 88.6% and mild in 11.4%. In patients undergoing isolated AVR, the cumulative probability of pacemaker implantation was 13.9% at 30 days, 15.5% at 1 year, and 21.8% at 7 years. Conclusions: AVR for aortic stenosis using an RDV is associated with low rates of late adverse events. This surgical pericardial tissue platform provides excellent and stable hemodynamic performance through 7 years.

Influence of surgical volume on outcomes in low-risk patients undergoing isolated surgical aortic valve replacement.

BACKGROUND: Intermediate- and high-risk patients undergoing isolated surgical aortic valve replacement have superior outcomes at higher-volume compared with lower-volume hospitals. This study examines the impact of hospital volume on outcomes in low-risk patients undergoing aortic valve replacement. METHODS: Using data from our 29 North Texas hospital collaborative, we examined 2066 low-risk cases (Society of Thoracic Surgeons Predicted Risk of Mortality of ≤3%) undergoing aortic valve replacement surgery between January 1, 2012, and December 31, 2017. Cases from 3 high-volume hospitals (≥200 aortic valve replacement cases total) and 26 low-volume hospitals (<200 cases total) were examined. RESULTS: Some 53.5% of the cases were at high-volume hospitals. No statistical differences were seen in the Predicted Risk of Mortality or pertinent demographics between the high-volume and low-volume hospitals. Significant differences in outcomes were seen between the 2 groups in operative mortality (2.28% vs 1.19%, P = .007), renal failure (2.14% vs 1.00%, P = .003), and readmission within 30 days (9.72% vs 6.25%, P < .001) when comparing low-volume with high-volume hospitals. In patients undergoing aortic valve replacement, undergoing the procedure in a low-volume hospital was an independent predictor for operative mortality (odds ratio, 1.95; 95% confidence interval, 1.20-3.20; P = .008) and renal failure (odds ratio, 2.25; 95% confidence interval, 1.33-3.81; P = .003). CONCLUSIONS: Operative mortality in low-risk patients undergoing aortic valve replacement is higher in low-volume compared with high-volume hospitals. The probability of a major complication, such as renal failure, is also greater in low-volume hospitals. The relationship between volume and outcomes in low-risk patients will require more research to understand the causes and design appropriate interventions.

Fungal endocarditis after transfemoral aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) was introduced in 2006 as an alternative for surgical aortic valve replacement (SAVR) as treatment for patients with aortic stenosis. Endocarditis after TAVI has been anecdotally reported, but concerns aroused because SAVR is often needed to explant the endocarditic valve in a high risk patient previously deemed not to be a surgical candidate. We report a case of a patient who underwent TAVI because he was too high risk to undergo SAVR. Several months later, he developed an intermittent self-limiting fever of unknown origin which eventually was diagnosed as endocarditis. The valve was surgically removed, and pathology showed an infection caused by Histoplasma capsulatum. The patient recovered fully and remains in good condition.

Mitral valve surgery: comparison of outcomes in matched sternotomy and port access groups.

BACKGROUND AND AIM OF THE STUDY: The 30-day outcomes were compared between matched groups of patients undergoing mitral valve procedures through Port Access (femoral cannulation, percutaneous retrograde cardioplegia and aortic occlusion), and through a sternotomy. METHODS: By using a Society of Thoracic Surgeons (STS)-certified, audited database, a total of 1108 patients was identified who were operated on between January 1996 and November 2008. A total of 608 mitral valve repair (MV-Rpr) patients (including 241 with Port Access procedures) and 500 mitral valve replacement (MVR) patients (including 45 with Port Access procedures) was included. Matching groups were created for 177 MV-Rpr patients (matched on preoperative cerebrovascular accident (CVA), previous coronary artery bypass grafting (CABG) and valve procedures, urgent operative status, mitral stenosis, heart failure, NYHA class IV, and age) and for MVR patients with 43 matches (matched for previous CABG surgery, operative status, NYHA class IV, and mitral insufficiency). RESULTS: Patients with Port Access procedures for MV-Rpr had a shorter length of hospital stay (5.4 +/- 2.8 versus 7.3 +/- 5.8 days), less postoperative ventilator usage (8.4 +/- 36.0 versus 24.8 +/- 81.6 h) and a shorter intensive care unit (ICU) stay (34.0 +/- 40.5 versus 81.7 +/- 133.8 h) when compared to sternotomy cases. Port Access also resulted in fewer patients requiring postoperative ventilation (50.3% versus 76.9%; p < 0.001) or reoperation for bleeding (2.3% versus 6.8%; p = 0.048). In MVR patients, Port Access use led to reductions in mortality (11.6% versus 0%; p = 0.021), ventilation time (13.8 +/- 40.3 versus 38.1 +/- 83.0 h), ICU stay (51.9 +/- 83.4 versus 152.4 +/- 125.0 h) and postoperative hospital stay (8.2 +/- 8.0 versus 11.0 +/- 8.6 days). In both groups, the cross-clamp time was longer with Port Access (107.7 +/- 26.8 versus 92.8 +/- 35.2 min for MV-Rpr; 130.2 +/- 44.2 versus 102.7 +/- 64.6 min for MVR). CONCLUSION: The performance of mitral valve surgery through a Port Access approach led to a reduction in ICU time, ventilator time, and hospital stay when compared to sternotomy. No increase in morbidity was observed with Port Access compared to sternotomy.

The occurrence of postoperative pulmonary homograft stenosis in adult patients undergoing the Ross procedure.

BACKGROUND AND AIM OF THE STUDY: The Ross procedure employs an autologous pulmonary valve to replace the aortic valve, but requires pulmonary homograft replacement. Concerns regarding long-term homograft function may limit the adoption of this technique. Herein, the incidence of, and factors leading to, stenosis of the homograft were examined. METHODS: Data were collected from 131 patients (32 females, 99 males) who underwent a Ross procedure between July 1994 and December 2003. Complete follow up data were collected from 113 of 125 (90.4%) living patients. Donor valve information, including storage time, was supplied by the graft manufacturers. Data were analyzed using chi-square tests, t-test and logistic regression. RESULTS: The mean patient follow up was 703 +/- 574 days (median 599 days; range: 2 to 2,408 days). Echocardiographic stenosis had occurred in 14 patients (12.4%). Four patients (3.2%) required homograft replacement, and two required balloon valvuloplasty. There was no significant difference in graft vendor, recipient, donor age or blood type match between stenotic and non-stenotic recipients. Donor valve size was appropriate for the recipients, and greater than predicted by recipient body surface area (BSA). Donor valves that developed stenosis had a shorter storage time after processing (160 +/- 100 versus 249 +/- 223 days; p = 0.03). Male donor valves became stenotic in 9.9% (7/71) of male recipients, but in none of 20 females. Female donor valves became stenotic in 27.3% (3/11) of male recipients, and in 28.6% (2/7) females. Logistic regression showed donor gender to be a significant predictor for stenosis (p = 0.007; odds ratio 14.1 for female/male donors; 95% CI 2.1-96.4). CONCLUSION: Donor valves which developed stenosis had a shorter mean cryopreservation time than those that did not develop stenosis. In addition, female donor homografts appeared to develop stenosis at a greater rate, independent of patient age, graft size to BSA match, and blood type.

Does reporting of coronary artery bypass grafting from administrative databases accurately reflect actual clinical outcomes?

OBJECTIVES: Quality assessment of coronary artery bypass grafting has traditionally been performed with data from clinical databases. Administrative databases that rely primarily on information collected for billing purposes increasingly have been used as tools for public reporting of outcomes quality. The correlation of administrative data with clinical data for clinical quality assessment has not been confirmed. METHODS: With data from a clinical database, we analyzed the outcomes of all patients who underwent coronary artery bypass grafting surgery in 1 hospital between 1999 and 2001. This information was collected before, during, and after the surgery and hospitalization by designated clinical individuals involved with the patient's care and then entered into an audited clinical database (The Society of Thoracic Surgeons National Cardiac Database). These data were then compared with administrative data collected on the same cohort of patients for the number of procedures performed and mortality rate as reported by the federal government (Medical Provider Analysis and Review), state government (Texas Health Care Information Council), hospital system (HCA, Inc, Casemix Database), and an internet Web site (healthgrades.com). Data were analyzed on the basis of the population reported, definitions used, risk assessment algorithms, and case volumes. RESULTS: By using the audited The Society of Thoracic Surgeons database as the standard and aggregating the reporting of case volumes by the inclusion criteria of various sources of administrative data, we found variances in the reported procedure volumes and mortality. Case volumes were overreported by as much as 21% in all patients and underreported by up to 16% or more in Medicare patients. Mortality in administrative data exceeded that reported in clinical data by 21%. Reasons for variances included time period reported (calendar vs fiscal year), population reported (all patients, Medicare patients, Medicare patients aged >/= 65 years), date used for the patient record captured (date of surgery, discharge), and the definition of mortality. Different proprietary risk-adjusting algorithms used magnified variances with risk-adjusted mortality exceeding the Society of Thoracic Surgeons data by as much as 61%. CONCLUSIONS: Substantial variability of reported outcomes is seen in administrative data sets compared with an audited clinical database in the end points of the number of procedures performed and mortality. This variability makes it challenging for the nonclinician unfamiliar with outcomes analysis to make an informed decision.

Mitral valve surgery using the classical 'heartport' technique.

BACKGROUND AND AIM OF THE STUDY: Mitral surgery in selected patients using femoral cannulation, percutaneous retrograde cardioplegia and endoballoon aortic occlusion with a 4-5 cm thoracotomy is felt to carry a higher operative risk than sternotomy with conventional cannulation. Herein, the authors compared their experience of the first 117 'Heartport' (HP) patients with a computer-matched group of sternotomy approach surgical patients (SP) to assess operative risk and 30-day outcome. METHODS: Data were extracted from the authors' STS certified, audited database on 117 patients based on an intention to treat. Between December 1997 and December 2004, a total of 92 isolated mitral valve (MV) repair (HP-MVRpr) and 25 isolated MV replacement (HP-MVR) procedures was conducted using Heartport. The patients were matched 1:1 (by age +/-7 years, cerebrovascular disease, inotrope use, and ejection fraction +/- 5%) to a control SP group. Operative and 30-day outcomes were measured. RESULTS: No parameter showed any significant difference in 30-day outcome between the HP and SP groups, except for an increase in cross-clamp and perfusion times. Two patients in the HP-MVRpr group required conversion to sternotomy for repair of coronary sinus perforation, and one patient was repaired without conversion. Surgery in one HP-MVRpr patient was aborted due to limited aortic dissection, but successful repair was carried out later with a conventional approach. No patient required conversion to sternotomy for improved exposure of the operative site. CONCLUSION: Despite a longer cross-clamp time, 'classical' HP MV surgery can be performed with no increased risk compared to conventional MV surgery. Catheter and endoballoon complications were rare even in the early experience, and conversion to sternotomy was unusual and safely performed with this approach.

Contemporary real-world outcomes of surgical aortic valve replacement in 141,905 low-risk, intermediate-risk, and high-risk patients.

BACKGROUND: The introduction of transcatheter aortic valve replacement mandates attention to outcomes after surgical aortic valve replacement (SAVR) in low-risk, intermediate-risk, and very high-risk patients. METHODS: The study population included 141,905 patients who underwent isolated primary SAVR from 2002 to 2010. Patients were risk-stratified by Society of Thoracic Surgeons (STS) predicted risk of mortality (PROM) <4% (group 1, n = 113,377), 4% to 8% (group 2, n = 19,769), and >8% (group 3, n = 8,759). The majority of patients were considered at low risk (80%), and only 6.2% were categorized as being at high risk. Outcomes were analyzed based on two time periods: 2002 to 2006 (n = 63,754) and 2007 to 2010 (n = 78,151). RESULTS: The mean age was 65 years in group 1, 77 in group 2, and 77 in group 3 (p < 0.0001). The median STS PROM for the entire population was 1.84: 1.46% in group 1, 5.24% in group 2, and 11.2% in group 3 (p < 0.0001). Compared with PROM, in-hospital mean mortality was lower than expected in all patients (2.5% vs 2.95%) and when analyzed within risk groups was as follows: group 1 (1.4% vs 1.7%), group 2 (5.1% vs 5.5%), and group 3 (11.8% vs 13.7%) (p < 0.0001). In the most recent surgical era, operative mortality was significantly reduced in group 2 (5.4% vs 6.4%, p = 0.002) and group 3 (11.9% vs 14.4%, p = 0.0004) but not in group 1. CONCLUSIONS: Nearly 80% of patients undergoing SAVR have outcomes that are superior to those by the predicted risk models. In the most recent era, early results have further improved in medium-risk and high-risk patients. This large real-world assessment serves as a benchmark for patients with aortic valve stenosis as therapeutic options are further evaluated.

Safety and efficacy of minimally invasive atrial septal defect closure.

BACKGROUND: Atrial septal defects (ASDs) have been surgically closed with low mortality utilizing the conventional sternotomy approach (CSA). The technical ease of ASD closure has triggered interest in minimally invasive closure (MIC) to obviate the morbidity associated with sternotomy. Our study assesses the safety and efficacy of minimally invasive ASD closure. METHODS: Preoperative, intraoperative, and postoperative data were collected on 68 patients (39 CSA, 29 MIC) who underwent ASD closure from January 1997 to August 2002. Using univariate analysis of 17 preoperative risk factors there was no statistically significant difference between the two groups. RESULTS: MIC resulted in equivalent success rates in ASD closures, with similar morbidity, no mortality, and a significant difference in postoperative length of stay (3.93 +/- 1.6 days versus 5.36 +/- 2.51 days, p = 0.006). CONCLUSIONS: In experienced hands, MIC is an excellent alternative to CSA in ASD closure.

Conversion in off-pump coronary artery bypass grafting: an analysis of predictors and outcomes.

BACKGROUND: The incidence, predictive factors, and outcomes related to conversion from off-pump coronary artery bypass (OPCAB) to on-pump coronary artery bypass grafting (ONCAB) have not been well defined. We sought to determine the incidence of conversion, predictive factors, and any associated adverse consequences. METHODS: From January 2000 through June 2002, 1,644 patients underwent nonemergent OPCAB with 61 patients requiring conversion from OPCAB to ONCAB. These groups were retrospectively compared by univariate and multivariate regression analysis. The converted group was then computer matched 1:3, to a cohort of ONCAB patients to determine differences in outcomes. RESULTS: The overall conversion rate was 3.71%. Converted patients compared with a computer-matched ONCAB patients had a higher incidence of operative mortality (18.0% versus 2.7%, p < 0.001). Urgently converted patients had a higher incidence of postoperative cardiac arrest (25% versus 1.1%, p < 0.001), multisystem organ failure (10.7% versus 0.6%, p < 0.001), vascular complications (7.1% versus 1.1%, p = 0.03), and perioperative myocardial infarction (10.7% versus 1.1%, p = 0.02). Predictive factors for conversion were surgeon early in OPCAB experience (odds ratio [OR] 4.4), previous CABG (OR 2.8), and congestive heart failure (OR 2.0). The need for urgent-emergent conversion was highly predictive for operative mortality (OR 7.3) compared with elective conversion. CONCLUSIONS: Patients undergoing urgent-emergent but not elective conversion from OPCAB to ONCAB had a significantly higher risk of mortality and morbidity compared with patients whose procedure was initially ONCAB. Variables predictive of conversion included previous CABG, congestive heart failure, and surgeons early in OPCAB experience.

First-year outcomes of beating heart coronary artery bypass grafting using proximal mechanical connectors.

BACKGROUND: To determine the extended results of mechanical connectors we compared the 1-year outcomes of patients having beating heart coronary artery bypass surgery with at least one sutured or mechanically connected proximal vein graft anastomosis. METHODS: From May 2001 to December 2001, 166 patients were identified as having undergone off-pump bypass grafting utilizing at least one St. Jude symmetry aortic connector (St Jude Medical Anastomotic Technology Group, St. Paul, MN). Follow-up for major adverse cardiac events (MACEs), which is defined as cardiac mortality, myocardial infarction, or revascularization of a previous target vessel, was obtained on 162 patients (97.6%). A control group of 159 patients was identified from a cohort of patients having beating heart surgery with one or more sutured proximal vein graft anastomosis in the preceding year. The MACE follow-ups were obtained in 136 patients (85.6%) by direct telephone contact. RESULTS: Patients with connectors showed an accelerated number of MACEs beginning approximately 180 days from the time of surgery and stabilizing at approximately 300 days. Logistic regression analysis identified the presence of diabetes as a significant preoperative risk factor predisposing patients to earlier onset of MACEs (p = 0.03) with an odds ratio of 2.9 (95% confidence interval, 1.1 to 7.6). Insulin dependent diabetics showed no differences between connector and control patients in the frequency or timing of MACEs. Connector patients using oral hypoglycemic agents demonstrated a significant deviation (p = 0.01) from a similar control population in the prevalence and timing of MACEs. CONCLUSIONS: Connector patients showed an increased incidence of early MACEs. These events were characterized by an increased requirement for early target vessel revascularization and were predominantly in noninsulin-dependent diabetics.

Obliteration of femoral artery pseudoaneurysm by thrombin injection.

BACKGROUND: Femoral artery pseudyoaneurysms are a common complication after femoral access for transcatheter procedures, frequently requiring operative repair. We review the safety and efficacy of a novel nonsurgical method of pseudoaneurysm treatment METHODS: From June 1998 to November 2001, a total of 47 femoral artery pseudoaneurysms in 46 patients were treated by bedside ultrasound-guided injection of dilute topical thrombin. All pseudoaneurysms occurred after femoral access for transcatheter procedures, and were diagnosed clinically and confirmed with ultrasound imaging. Clinical follow-up was performed and included ultrasound (2 hours to 1 month) in 64.4% of patients, including any patient with a symptomatic or clinical change. RESULTS: Pseudoaneurysms ranged in size from 1.5 to 4.5 cm. Of 47 pseudoaneurysms, 45 were successfully obliterated on the initial injection. After successful obliteration of pseudoaneurysm, 1 patient sustained thrombosis of the tibioperoneal trunk that required surgical embolectomy, yielding a complication rate of 2%. Four pseudoaneurysms recurred after initially successful obliteration. In 1 of these cases, the patient was taken directly to surgery, and 3 were successfully treated with repeat injection, for an overall success rate of 93.6%. CONCLUSIONS: Obliteration of femoral artery pseudoaneurysm by injection is safe and effective, and may be associated with decreased morbidity. Recurrent pseudoaneurysms may be safely reinjected, with a high success rate.

Initial experience with proximal anastomoses performed with a mechanical connector.

BACKGROUND: The Symmetry Bypass System Aortic Connector (St Jude Medical, Inc) is a novel device for the construction of sutureless proximal anastomoses. The connector allows attachment of saphenous vein grafts to the aorta without requiring aortic clamping. We report our initial clinical experience with this device. METHODS: In a 2-month period from May to July 2001, a total of 139 consecutive proximal anastomoses were performed in 67 patients using the connector. All procedures were performed on a beating heart without cardiopulmonary bypass or any aortic clamping. Intraoperative variables and postoperative results were prospectively collected and retrospectively analyzed. RESULTS: Of 139 consecutive proximal anastomoses 138 (99.3%) were successfully completed with the device. One anastomosis required suture revision because of misdeployment. Six anastomoses (4.3%) required an additional suture for leak. Predeployment problems included connector loading/preparation malfunction in 10 grafts (7.2%), five because of human error and five technical failure. There was no operative mortality, perioperative myocardial infarction, or stroke. Vessels bypassed included the circumflex system (n = 59), right coronary artery and branches (n = 48), diagonal branch (n = 26), and left anterior descending coronary artery (n = 6). At a mean follow-up of 7 months, survival was 94.1% and survival free of major adverse cardiac and cerebrovascular events (MACCE) was 88.1%. CONCLUSIONS: Initial clinical experience with a sutureless proximal saphenous vein graft to aorta anastomosis performed with a mechanical connector demonstrates safety, reliability, and ease of use. Surmounting a brief learning curve improves the subtleties of device loading and deployment. Further benefits will be determined in an ongoing randomized study.

Elimination of cardiopulmonary bypass improves early survival for multivessel coronary artery bypass patients.

BACKGROUND: Coronary artery bypass graft (CABG) surgery performed without cardiopulmonary bypass (CPB) is currently increasing in clinical practice. Decreased morbidity associated with off-pump (OP) CABG in selected risk groups examined in relatively small, single institution groups has been the focus of most recent studies. The purpose of this study was to determine the independent impact of CPB on early survival in all isolated multivessel CABG patients undergoing surgery in two large institutions with established experience in OPCABG techniques. METHODS: A review of two large databases employed by multiple surgeons in the hospitals of two institutions identified 8,758 multivessel CABG procedures performed from January 1998 through July 2000. In all, 8,449 procedures were included in a multivariate logistic regression analysis to determine the relative impact of CPB on mortality independent of known risk factors for mortality. Procedures were also divided into two treatment groups based on the use of CPB: 6,466 had CABG with CPB (CABG-CPB), 1,983 had CABG without CPB (OPCABG). Disparities between groups were identified by univariate analysis of 17 preoperative risk factors and treatment groups were compared by Parsonnet's risk stratification model. Finally, computer-matched groups based on propensity score for institution selection for OPCABG were combined and analyzed by a logistic regression model predicting risk for mortality. RESULTS: CABG-CPB was associated with increased mortality compared with OPCABG by univariate analysis, 3.5% versus 1.8%, despite a lower predicted risk in the CABG-CPB group. CPB was associated with increased mortality by multiple logistic regression analysis with an odds ratio of 1.79 (95% confidence interval = 1.24 to 2.67). An increased risk of mortality associated with CPB was also determined by logistic regression analysis of the combined computer-matched groups based on OPCABG-selection propensity scores with an odds ratio of 1.9 (95% confidence interval = 1.2 to 3.1). CONCLUSIONS: Elimination of CPB improves early survival in multivessel CABG patients. Rigorous attempts to statistically account for selection bias maintained a clear association between CPB and increased mortality. Larger multiinstitutional studies are needed to confirm these findings and determine the most appropriate application of OPCABG.

Complications related to off-pump bypass grafting.

Surgical myocardial revascularization is a technique undergoing critical reevaluation in an attempt to reduce operative morbidity and mortality. As the age and number of comorbidities in the surgical population presenting for bypass increases, improved strategies to lessen operative risk have evolved. The use of off-pump bypass grafting to avoid the detrimental effects of extracorporeal circulation demonstrates great promise in reducing operative complications. However, with new techniques come new challenges. Avoidance of the cardiopulmonary bypass circuit has been linked to the development of a hypercoagulable state postoperatively. Complications related to the unique management of the ascending aorta and target vessels during the performance of beating heart surgery are also being reported. Moreover, despite increasing experience in a number of centers, hemodynamic collapse does occur during off-pump bypass, thereby requiring rapid institution of cardiopulmonary bypass. Continued scientific investigation and research should provide the tools to manage the unique obstacles encountered with off-pump coronary artery bypass.

Experience with various surgical options for the treatment of atrial fibrillation.

BACKGROUND: New alternatives exist using various energy sources and lesion lines for the surgical treatment of atrial fibrillation (AF). The efficacy of these options compared to the cut-and-sew maze III procedure is unknown. METHODS: From August 1996 to August 2003, 79 patients have undergone a procedure for AF, with 70 patients currently more than 3 months postsurgery. The patients (58 continuous, 12 paroxysmal) underwent a surgical procedure for AF, lone AF (12) and with concomitant procedures (58). Techniques included cut and sew (23), bipolar radiofrequency (RF) (28) and unipolar-RF (10), and cryothermy (9). Lesions included maze III (46), pulmonary vein isolation (16), and pulmonary vein isolation plus mitral annular connecting line only (8). RESULTS: Follow-up was complete in 58 (83%) of 70 patients at a mean time of 595 +/- 750 days (range, 24-2530 days). The operative mortality was 0% in lone AF patients and 7.1% (5/70) in patients undergoing concomitant procedures. Need for perioperative pacemaker was 22.9%. Overall, normal sinus rhythm (NSR) was restored in 82.7% of patients, with success in 83.3% (10/12) lone procedures and 82.6% (38/46) concomitant procedures ( P = NS); the rate of continuous AF was 85.1% (40/47) and SR with paroxysmal fibrillation was 72.7% (8/11) ( P = NS). Traditional maze was successful in 80.6% (29/36) patients, pulmonary vein isolation was successful 93.3% (14/15), and left-sided maze in 71.4% (5/7) ( P = NS). Cut and sew procedures were successful in 88.2% (15/17), RF-bipolar in 84.0% (21/25), RFunipolar in 77.8% (7/9), and cryothermy in 71.4% (5/7) ( P = NS). Energy source, lesion set, AF duration, and lone/concomitant procedure were the factors subjected to logistic regression analysis. No factors were predictive of achieving postoperative NSR. CONCLUSIONS: Our early experience with newer surgical techniques employing different energy sources and fewer incision lines suggests that the success rate may approach the results obtained with traditional cut-and-sew Cox-maze III procedures.