Invited commentary.
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Aortic Valve Insufficiency↗
Biomedical subjects
Robert W Emery
Publications and source records attributed to Robert W Emery.
St Jude Medical Regent valve.
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Aortic Valve↗
The St. Jude Medical cardiac valve prosthesis: a 25-year experience with single valve replacement.
BACKGROUND: From October 1977 to October 2002, 4,480 patients (age range, 17 to 94 years; average, 64 +/- 13 years) underwent single valve replacement with the St. Jude Medical heart valve. Of 2,982 aortic (AVR) and 1,498 mitral valve replacements (MVR), concomitant coronary artery bypass grafting was performed on 42% and 33%, respectively. METHODS: Cardiac Surgical Associates has maintained an independent database of patients having valve replacement with the St. Jude Medical prosthesis since the world's first implant. Patients were contacted by questionnaire or phone from November 2002 through June 2003. Hospital course and valve-related events were verified by patient chart review or physician contact. RESULTS: Follow-up was 95% complete. Operative mortality was 4% with AVR and 9% with MVR. Total follow-up was 32,190 patient-years (range, 1 month to 24.8 years; average, 7 +/- 5 years). During the study period, patient freedom from late mortality was 61% (AVR, 61%; MVR, 63%), and from valve-related mortality 92% (AVR, 93%; MVR, 91%). Freedom from thromboembolic events was 85% (86% AVR, 81% MVR), from bleeding events, 81% (81% AVR, 81% MVR), from reoperation, 98% (99% AVR, 97% MVR), from endocarditis, 98% (99% AVR, 98% MVR), and from valve thrombosis, 99% (99% AVR, 98% MVR). There was one MVR structural failure (0.06%). CONCLUSIONS: The St. Jude Medical valve has proven to be an effective and durable valve prosthesis with a low event rate during the long term.
Adolescent↗
Initial report of off-pump coronary artery bypass surgery as sole therapy for moderate ischemic mitral regurgitation: operative and intermediate-term outcome.
BACKGROUND: Patients undergoing on-pump coronary artery bypass surgery (CAB) with coexistent moderate ischemic mitral regurgitation (IMR) have a significant mortality rate compared to patients without MR. The mortality rate is elevated both perioperatively (0%-12% mortality), as well as over a 1- and 2-year postoperative period (15%-25%). It is thought that some patients are best served by off-pump CAB (OPCAB); however, outcomes have not been reported for such patients with coexistent moderate IMR. METHODS: We reviewed the independent database of patients undergoing OPCAB between 1995 and 2002 to find 989 patients, 17 (1.7%) of whom had moderate or moderately severe MR. Patients were contacted and clinical and echocardiographic data were obtained. RESULTS: The patient group consisted of 11 men and 6 women (age, 65 +/- 15 years). The study group had a PA pressure of 52 +/- 14, creatinine of 1.6 +/- 0.7, and left ventricular ejection fraction of 43 +/- 18. Nine patients (53%) had advanced New York Heart Association (class III-IV) heart failure. Mortality rates perioperatively and at 1, 2, and 3 years were 0%, 6.25% (1/16), 12.5% (2/16), and 38% (4/8), respectively. At the time of this report, no patient had returned for a reparative procedure. CONCLUSION: In patients felt to be best served by OPCAB with ischemic MR, operative and intermediate mortality rates are remarkably similar to those previously reported for on-pump series. These data underscore the continued need to understand which patients undergoing CAB require mitral valve problems to be addressed at the time of surgery.
Aged↗
Minimally invasive technique proves useful.
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Aged↗
Description and evaluation of a ventriculo-coronary artery bypass device that provides bi-directional coronary flow.
OBJECTIVE: The objective of this study was to assess acute patency of a new myocardial revascularization device that connects the left ventricular cavity to a coronary artery (termed ventriculo-coronary artery bypass, VCAB) thereby providing proximal and distal blood flow from the site of the anastomosis. METHODS: A device made of expanded polytetrafluoroethylene and low density polyethylene was implanted from the base of the left ventricle to the mid left anterior descending coronary artery (LAD) in 11 juvenile domestic pigs using a beating heart approach. Flow rates were measured in the distal LAD before and after implant using ultrasonic flow techniques, and patency was assessed at explant at either 2 or 4 weeks post-implantation. Myocardial perfusion using positron emission tomography (PET) was assessed in a separate set of pigs (n=2) revascularized by VCAB 2 weeks post-implant. RESULTS: Net forward flow distal to the implanted device was 73 +/- 15% of native LAD flow. PET demonstrated that the target myocardium was perfused at 85% of that seen in the remote, control myocardium. Device patency rate was 80% (4/5) at 2 weeks in one set of pigs and 83% (5/6) at 4 weeks in a second set of pigs. Histologic analysis showed formation of neointima along the extraventricular segment of the device. CONCLUSIONS: This study demonstrates the promise of perfusing ischemic myocardium using a VCAB approach with a device that provides blood flow both proximal and distal to the anastomosis. Patency of the transmyocardial device was encouraging at 2 and 4 weeks and warrants further investigation.
Animals↗
Opposite trends in coronary artery and valve surgery in a large multisurgeon practice, 1979-1999.
BACKGROUND: Trends in coronary artery bypass (CAB) and valve operations (VO) may help predict the future of cardiac surgery in the context of changing case mix, shifting paradigms, emerging technology, and population demographics. METHODS: We retrospectively reviewed all 30,319 adult CAB and VO in our group from 1979 to 1999 according to specific procedures. RESULTS: Coronary artery bypass volumes peaked in 1996 at 1,895 cases, declining 15.3% to 1,605 cases in 1999 with a decrease in risk profile and percent reoperations and an increase in mean age and percent octogenarians, prior percutaneous coronary interventions (PCI), left internal mammary artery (LIMA) graft usage, off-pump technology usage, and hospital mortality of reoperations. Right internal mammary grafts were employed infrequently and radial artery grafts transiently. Overall VO volumes continued to increase 24.0% since 1996, from 470 to 583 cases with a decreased risk profile, increased mean age, and percent octogenarians and prior PCI. The percentage of mechanical valve implants decreased, while the percentage of various tissue solutions for valve disease increased. Limited access incisions and port-access were employed transiently with CAB and VO. CONCLUSIONS: Coronary artery bypass volumes are decreasing, with an increasing percentage of LIMA grafts and off-pump cases. Valve operation volumes are steadily increasing, with a decreasing percentage of mechanical valve implants, in favor of various tissue solutions.
Adult↗
Five-year follow up of the ATS mechanical heart valve.
BACKGROUND AND AIM OF THE STUDY: Between January 1, 1997 and December 31, 2001, a total of 342 patients underwent aortic valve replacement (AVR) or mitral valve replacement (MVR) with the ATS Medical prosthesis. The initial three-year phase of this study took place under a United States Food and Drug Administration-approved investigational device exemption study. The study aim was to determine the incidence of valve-related events in up to five years of follow up after valve implantation, and to assess patient disturbance from valve noise. METHODS: Patients were consecutively enrolled to undergo AVR or MVR with the ATS prosthesis. Follow up studies were conducted by patient questionnaire and/or telephone call. Follow up was 96% complete. AVR was conducted in 246 patients (80 with coronary bypass), and MVR in 96 patients (29 with coronary bypass). RESULTS: The overall operative mortality was 2.6% (n = 9; AVR 3.2%, n = 8; MVR 1.0%, n = 1), with two deaths being valve-related (0.6%). In 878 patient-years (pt-yr) of follow up (613 pt-yr for AVR; 265 pt-yr for MVR) there were an additional 22 deaths. Five deaths (0.6%/pt-yr) were valve-related: two were neuroembolic (both MVR), one from endocarditis (AVR), and two from bleeding events (both AVR). Late valve-related complications (>30 days) included 17 episodes of major bleeding (11 AVR, 1.8%/pt-yr; six MVR, 2.3%/pt-yr), five permanent neuroembolic events (four AVR, 0.7%/pt-yr; one MVR, 0.4%/pt-yr); 16 transient neuroembolic events (10 AVR, 1.6%/pt-yr; six MVR, 2.3%/pt-yr); three transient peripheral emboli (two AVR, 0.3%/pt-yr; one MVR, 0.4%/pt-yr); four paravalvular leaks (two AVR, 0.3%/pt-yr; two MVR, 0.8%/pt-yr); and one episode of valve thrombosis (MVR, 0.4%/pt-yr; AVR, 0%/pt-yr). Reoperation was required in two patients: one AVR (paravalvular leak, 0.2%/pt-yr) and one MVR (replacement due to thrombosis, 0.4%/pt-yr). CONCLUSION: These results indicate that intermediate-term results with the ATS mechanical prosthesis continue to be excellent, though further long-term follow up is warranted.
Adult↗
Clinical, angiographic, and interventional follow-up of patients with aortic-saphenous vein graft connectors.
BACKGROUND: The use of aortic connectors for proximal saphenous vein bypass graft anastomoses eliminates the need for aortic clamping during coronary artery bypass grafting (CABG) and may reduce the incidence of stroke in the elderly and in patients with severe aortic atherosclerosis. METHODS AND RESULTS: We studied 74 consecutive patients who received the Symmetry Bypass System aortic connector at the time of CABG. A total of 131 of 144 proximal vein graft anastomoses were performed with this device. The left internal mammary artery was used in 62 patients, and 61 patients had "off-pump" coronary revascularization. A total of 11 patients were readmitted with chest pain consistent with unstable angina 173+/-39 days after CABG. Five of the 11 patients had previous in-stent restenosis before CABG. At angiography, 20 saphenous vein bypass grafts containing 19 connectors were found to have severe stenosis (n=12) or occlusion (n=6) and were treated with angioplasty and stenting or medical therapy. Seven of 11 patients were readmitted 76+/-11 days later with recurrent chest pain and were found to have severe stenosis at the previously stented connector site. Six patients underwent angioplasty followed by brachytherapy. Three of these patients redeveloped chest pain and were readmitted 151+/-71 days later. Two patients were started on oral Rapamune, and one patient underwent redo-CABG. CONCLUSIONS: Eleven of 74 patients who received aortic connectors at the time of CABG developed symptomatically significant stenosis or occlusion at the connector site shortly after CABG, requiring multiple repeat interventions, including brachytherapy.
Aged↗
The initial experience with the ATS Medical mechanical cardiac valve prosthesis.
BACKGROUND: From May 1994 through October 2000, a total of 1,146 patients underwent valve replacement with the ATS Medical mechanical cardiac valve prosthesis under a study protocol approved by international ethics committees (non-United States participants) or under a United States Food and Drug Administration-approved Investigational Device Exemption study. The study took place at 19 domestic and three international centers. METHODS: As required by the Food and Drug Administration's Heart Valve Guidance Document, only isolated implants were included in the study (double-valve implants were excluded), with operative and follow-up data collected from each center. RESULTS: Aortic valve replacement (AVR) was conducted in 801 patients (309 with coronary bypass) and mitral valve replacement (MVR) in 345 patients (78 with coronary bypass). Overall operative (< or = 30 days post implant) mortality was 2.1% (17 AVR = 2.1%, 7 MVR = 2.0%), 7 of which (AVR = 4, MVR = 3) were valve related. In 2,086 patient-years (1,459 AVR patient-years, 627 MVR patient-years) of follow-up, there were an additional 50 patient deaths of these, 18 were valve related, 9 due to anticoagulant related bleeding, 5 sudden/unexplained, and 1 each after stroke, thrombosis, prosthetic valve endocarditis, and thromboembolism. Late (>30 days post implant) valve-related complications included: transient and chronic thromboembolism (27 AVR (linearized rate 1.85%/patient-year) and 20 MVR (3.19%/patient-year), of which 11/47 (0.53%/patient-year) had chronic deficits, thrombosis (1 AVR = 0.07%/patient-year and 4 MVR = 0.64%/patient-year), paravalvular leak (10 AVR = 0.69%/patient-year and 8 MVR = 1.28%/patient-year), anticoagulant related hemorrhage (34 AVR = 2.33%/patient-year and 8 MVR = 1.28%/patient-year), prosthetic valve endocarditis (3 AVR = 0.21%/patient-year and 2 MVR = 0.32%/patient-year), and structural valve failure or dysfunction (0%). Echocardiographic gradients were proportional to valve size and did not significantly change over the follow-up period. CONCLUSIONS: This study documented the ATS Medical mechanical cardiac valve prosthesis to be a valuable addition to the surgeon's armamentarium in the treatment of cardiac valvular disease.
Aged↗
Replacement of the aortic valve in patients under 50 years of age: long-term follow-up of the St. Jude Medical prosthesis.
BACKGROUND: Aortic valve replacement in the young adult (aged 18 to 50 years) is a choice between a mechanical prosthesis with attendant lifelong anticoagulation or biological prostheses of varying types that may have limited life expectancy in this age group. METHODS: The Cardiac Surgical Research Foundation database was accessed to determine long-term outcomes in patients having aortic valve replacement with the St. Jude Medical Valve. This database has been privately maintained since the world's first St. Jude Medical (SJM) valve implant in 1977. Patients were contacted by questionnaire or by telephone if the survey was not returned. Follow-up was 93% complete. RESULTS: From October 1977 through October 1997, 271 patients less than 50 years of age had isolated aortic valve replacement. Follow-up was 1957 patient years. Thirty-day operative mortality was 1.1% with 18 late deaths, 4 of which were valve related. Ninety percent of survivor INR responses indicated a frequency of monthly INR checks or less. Valve-related events including percent per patient year and mortality related to these events included thromboembolism, 6 episodes (0.3% per patient year, no deaths); anticoagulant-related bleeding, 6 events (0.3% per patient year, 2 deaths); paravalvular leak, 6 events (0.3% per patient year, 2 deaths); valve thrombosis, 2 events (0.1% per patient year, no deaths); and endocarditis, 3 events (0.15% per patient year, no deaths). There was no incidence of structural valve failure. CONCLUSIONS: The SJM valve has a long record of excellent performance with durability lasting more than 20 years. The incidence of untoward events is low and death over time due to valve-related complications is low (4 of 271). The SJM valve has become our valve of choice for younger patients.
Adolescent↗
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.
Adult↗
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.
Adult↗
Surgical steps toward complete revascularization in off-pump coronary bypass.
Surgical techniques aimed at complete myocardial revascularization without the use of cardiopulmonary bypass are described. Between January 1998 and June 2000, coronary artery bypass was performed in 3,003 patients; an off-pump technique was used in 676 and cardiopulmonary bypass was employed in 2,327. Patient characteristics, demography, and preoperative risk factors of the two groups were compared retrospectively, and differences in operative variables and postoperative outcomes were analyzed. Using a commercially available suction stabilization device and the surgical and anesthetic techniques described herein, off-pump coronary revascularization was accomplished with results comparable to the on-pump approach.
Aged↗
Cardiac valve surgery.
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Cardiac Surgical Procedures↗
Decision-making in the choice of heart valve for replacement in patients aged 60-70 years: twenty-year follow up of the St. Jude Medical aortic valve prosthesis.
BACKGROUND AND AIM OF THE STUDY: The choice of a cardiac valve for patients with aortic valvular pathology remains controversial. Younger patients may be at risk for long-term complications from chronic anticoagulation yet require prosthesis longevity, while older patients may not outlive a bioprosthesis. To gather information to help decision-making, the 20-year experience of aortic valve replacement (AVR) with the St. Jude Medical (SJM) valve by the surgeons of Cardiac Surgical Associates, P.A., was reviewed. METHODS: Cardiac Surgical Associates Research Foundation maintains a database of all patients undergoing valve replacement with the SJM aortic prosthesis since the world's first implant in October 1977. Patient follow up is conducted by questionnaire and/or telephone interview. The 20-year follow up period ended in October 1997. Follow up is 96.3% complete, and extends to 13,208 patient-years. RESULTS: A total of 2,390 aortic valves (1,500 in males, 890 in females) were replaced in the period studied. Among these patients, 1,419 had isolated AVR, whilst the remainder had AVR plus coronary artery bypass (CAB) or other procedures. The mean age was 63 +/- 14 years for AVR, and 70 +/- 10 years for AVR/CAB. Over the 20-year follow up period, freedom from valve-related events for the entire group was: thromboembolism, 97%; anticoagulant-related hemorrhage, 94%; valve thrombosis, 99.7%; prosthetic valve endocarditis, 99.2%; and paravalvular leak, 99.6%. Freedom from structural failure was 100%. Mortality for these events was low (15 deaths among 250 events; 6%). Overall survival at 5, 10, 15 and 19 years was 82, 66, 51 and 45% respectively for isolated AVR, and 72, 45, 25 and 15% respectively for AVR/CAB. CONCLUSION: The SJM valve has excellent hemodynamics and a low incidence of valve-related complications. Improvements in anticoagulation monitoring with the newly introduced and funded home monitoring program, as well as the introduction of newer and more effective antiplatelet drugs, will improve the safety of patients requiring chronic anticoagulation. With durability unquestioned, these long-term data show the SJM valve to be an excellent choice for AVR in patients aged 60-70 years.
Age Factors↗