Results from an Italian multicentric registry comparing heparin-bonded ePTFE graft and autologous saphenous vein in below-knee femoro-popliteal bypasses.

AIM: The aim of this study was to evaluate early and follow-up results of below-knee bypasses performed with a bioactive heparin-treated ePTFE graft in patients with peripheral arterial obstructive disease (PAOD) in a multicentric retrospective registry involving seven Italian vascular centers and to compare them with those obtained in patients operated on with autologous saphenous vein (ASV) in the same centres in the same period of time. METHODS: Over a nine-year period, ending in 2010, a heparin bonded prosthetic graft (Propaten Gore-Tex, W.L. Gore & Associates Inc, Flagstaff, AZ, USA) was implanted in 556 patients undergoing below-knee revascularization for PAOD (HePTFE group). In the same period of time 394 below-knee bypasses with ipsilateral ASV were performed (ASV group). Data concerning these interventions were retrospectively collected in a multicenter registry with a dedicated database. Early (<30 days) results were analyzed in terms of graft patency, major amputation rates and mortality. Follow-up results were analyzed in terms of primary and secondary graft patency, limb salvage and survival. RESULTS: Among patients of HePTFE group, 413 had critical limb ischemia (74%); the corresponding figure for ASV group was 84% (332 interventions, P<0.001). Eighty-nine patients in HePTFE group (16%) and 207 patients in ASV group (52.5%; P<0.001) had distal tibial anastomosis. Patients in HePTFE group had more frequently adjunctive procedures performed at distal anastomotic sites in order to improve run-off status. Thirty-day death rate was 1.9% in HePTFE group and 0.5% in ASV group (P=0.08). The rates of perioperative thromboses and amputations were 6% and 3.5% in HePTFE group, and 5% and 1.7% in ASV group, without significant differences between the two groups. Mean duration of follow-up was 28.5±22.1 months; 921 patients (97%) had at least one postoperative clinical and ultrasonographic control. Estimated 48-month survival rates were 81% in HePTFE group and 74% in ASV group (P=0.7, log rank 0.1). Primary patency rate at 48 months was significantly better in ASV group (61%) than in HePTFE group (44.5%; P=0.004, log rank 8.1). The rates of secondary patency at 48 months were 57% in HePTFE group and 67.5% in ASV group (P=0.1, log rank 1.9); the corresponding values in terms of limb salvage in patients with critical limb ischemia were 77% and 79.5% (P=0.3, log rank 0.9), respectively. CONCLUSION: Data from this large, retrospective registry confirmed that the indexed heparin-bonded ePTFE graft provides satisfactory early and mid-term results in patients undergoing surgical below-knee revascularization. While autologous saphenous vein maintains its superiority in terms of primary patency, secondary patency and limb salvage rates are comparable.

Treatment with daptomycin for Corynebacterium Jeikeium left-sided prosthetic valve endocarditis.

Prosthetic valve endocarditis (PVE) is a serious complication with potential fatal consequences, classified as early or late PVE, depending on whether typical symptoms occur within or later than 12 months from surgery. The incidence of early PVE is under 1%, but it carries high morbidity and mortality rates. There are few reported cases in literature of PVE due to Corynebacterium Jeikeium even though it is present in normal skin flora particularly in hospitalized patients. Corynebacterium species are, in fact, recognized as uncommon agents of endocarditis and little is known regarding species-specific risk factors and the outcome in this kind of endocarditis. Described is an unusual case report of a 57-year-old man who had early aortic PVE due to Corynebacterium Jeikeium infection complicated by dehiscence of the prosthesis, complete atrio-ventricular block, perforation of the interventricular septum and septic shock. Prompt diagnosis, choice of daptomycin as antibiotic therapy although it has only been approved by the European Medicine Agency (EMEA) for right-sided endocarditis and timely open heart surgery, resulted in a successful outcome.

Long-term mechanical support with the HeartMate II LVAS.

BACKGROUND: The use of left ventricular assist devices (LVAD) is an accepted therapy for patients with refractory heart failure. The HeartMate II is a small (350 g), implantable, axial-flow pump (nonpulsatile flow), which is designed to support the left ventricle for extended periods of time. Here we have reported our initial single-center clinical experience with this device as a bridge to heart transplantation. MATERIALS AND METHODS: Between March 2002 and December 2008, 18 transplantable adult patients were supported on long-term HeartMate II LVAS at our institution. The cohort included 15 men with an overall mean age of 52 +/- 8.4 years (range, 31-64 years). Primary indications for implantation were ischemic cardiomyopathy (CMP; n = 13) and idiopathic CMP (n = 5). All heart failure patients were New York Heart Association (NYHA) functional class IV. None of them had undergone prior open heart surgery. Implantation was performed via cannulation of the left ventricular apex and ascending aorta, and in each case was an elective procedure. RESULTS: Mean support time was 217 +/- 212.3 days (range, 1-665 days). Early (30-day) mortality was 27.7% (n = 5) due to multiple organ failure and sepsis as main causes of death. Bleeding requiring reoperation occurred in 6 cases (33.3%). Cerebral hemorrhage occurred in 1 case. There were 2 driveline infections and no device failure. Twelve subjects (66.6%) were successfully discharged home. Overall, 9 patients (50%) underwent transplantation and 3 are awaiting a suitable organ (2 were discharged home and 1 is in hospital). At latest follow-up, the survival rate after heart transplantation was 66.6% (n = 6). CONCLUSIONS: Long-term HeartMate II LVAS can successfully bridge patients to heart transplantation. Good mid- and long-term results may support the use of this device even for a permanent solution in nontransplantable subjects.

Bicuspid aortic valve disease and pulmonary autograft root dilatation after the Ross procedure: a clinicopathologic study.

OBJECTIVE: Bicuspid aortic valve disease has been associated with histologic abnormalities of the aortic root. Recent reports have suggested similar alterations may exist in the pulmonary artery of patients with bicuspid aortic valve. The present study was undertaken to define the histologic condition of the aortic and pulmonary artery root in bicuspid aortic valve disease and the relationship with pulmonary autograft root dilatation after the Ross procedure. METHODS: In 17 patients undergoing aortic root replacement with the pulmonary autograft, biopsy specimens of the aortic root and pulmonary artery trunk were collected. Clinical and histologic findings of patients with bicuspid aortic valves were compared with those with tricuspid aortic valves. RESULTS: There were 9 patients (8 male, 1 female) with bicuspid aortic valve (group 1) and 8 (all male) with tricuspid aortic valve (group 2). Mean age was comparable (24.4 +/- 9.8 vs 23.6 +/- 10.8 years, P =.9). Aortic insufficiency as an indication for operation was more common in group 1 (9/9 vs 5/8, P =.007), whereas preoperative aortic root dilatation was equally prevalent (4/9 vs 1/8, P =.1). Prior aortic valve repair had been performed in 2 patients (1/9 vs 1/8, P =.9). Prevalence of cystic medionecrosis of the aortic wall was similar in the 2 groups (4/9 vs 3/8, P =.6). Cystic medionecrosis of the pulmonary artery trunk was found only in 1 patient with tricuspid aortic valve (0/9 vs 1/8, P =.3). During a mean follow-up of 26.5 +/- 12.2 months (32.1 +/- 12.7 vs 20.1 +/- 7.4 months, P =.04), prevalence of pulmonary autograft root dilatation (greater than 4.0 cm) was equally represented in patients with native bicuspid or tricuspid aortic valve (3/9 vs 2/8, P =.6). CONCLUSIONS: Histologic abnormalities of the pulmonary artery root are rare and equally prevalent in young patients with bicuspid and tricuspid aortic valves. On the contrary, root dilatation is relatively common late after autograft root replacement but appears unrelated to bicuspid aortic valve disease or to pre-existing degenerative changes of the pulmonary artery root.

Over twenty-year follow-up of the standard Hancock porcine bioprosthesis implanted in the mitral position.

BACKGROUND: To define the long-term results of 331 standard Hancock porcine bioprostheses implanted in the mitral position between 1973 and 1980. METHODS: Of 331 patients (225 male patients, 68%), mean age 49+/-10 years (range 14 to 69 years), 88% were in New York Heart Association functional class III or IV and 77% were in atrial fibrillation. Follow-up time extended more than 20 years (mean 13.9 years, range 0.3 to 24.7 years) for a total of 4,601 patient-years. RESULTS: Overall operative mortality was 6.3%. At 5, 10, 15, and 20 years, the actuarial survival rate of patients were 71%+/-2%, 46%+/-3%, 30%+/-3%, and 22%+/-2%, respectively. Actuarial estimates of freedom from structural valve deterioration were 95%+/-1%, 67%+/-3%, 32%+/-3%, and 14%+/-3%; from reoperation were 96%+/-1%, 72%+/-3%, 36%+/-4%, and 18%+/-4%; from thromboembolism were 89%+/-2%, 82%+/-3%, 74%+/-4%, and 51%+/-2%; and from anticoagulant-related hemorrhage were 98%+/-1%, 96%+/-1%, 91%+/-1%, and 86%+/-4%. Estimates of freedom from all valve-related mortality at 5, 10, 15, and 20 years were 89%+/-2%, 76%+/-3%, 64%+/-4%, and 48%+/-4%. Multivariate analysis showed younger age to be a significant risk factor for reoperation. Age at operation did not correlate with structural valve deterioration. CONCLUSIONS: The long-term results with the standard Hancock bioprosthesis implanted in the mitral position appear satisfactory, particularly up to 15 years from implantation. Protection from stroke, anticoagulant hemorrhage, and endocarditis was good.

Comparison of late outcome after stentless versus stented xenograft aortic valve replacement.

The long-term outcomes of 292 patients having stented xenograft aortic valve replacement (AVR) (group 1) and 376 having stentless AVR (group 2) were compared. Patients in group 1 were older (75 +/- 9 years v 70 +/- 6 years, P =.01), had more advanced cardiac disease (New York Heart Association [NYHA] classification III-IV: 85% v 75%, P =.03), and more associated procedures (53% v 41%, P =.01). Early mortality was higher in Group 1 (6.2% v 2.6%, P =.02), primarily due to cardiac cause (5.4% v 1.5%, P =.009). During follow-up (37 +/- 30 months v 43 +/- 35 months, P = not significant [ns]), 66 late deaths were recorded (12% v 9%, P = ns). At 8 years, survival (70% +/- 5% v 81% +/- 3%, P =.01) freedom from cardiac death (85% +/- 1% v 92% +/- 3%, P =.02) and prosthesis-related death (79% +/- 5% v 95% +/- 2%, P =.004) was higher in Group 2, but freedom from structural deterioration was similar (92% +/- 5% v 93% +/- 3%, P = ns). Late functional status was equally satisfactory (NYHA classification I-II: 89% v 90%, P = ns). Stentless AVR may confer selective survival advantages. Because freedom from valve failure is similar to stented xenografts, extension of stentless AVR to patients without anatomic contraindications appears justified.

Long-term results with the Xenomedica porcine bioprosthesis in the mitral position.

BACKGROUND AND AIM OF THE STUDY: The study aim was to evaluate our clinical experience with the Xenomedica heart valve prosthesis, a low-pressure glutaraldehyde-preserved porcine aortic valve with low-profile mounting. METHODS: Between January 1983 and July 1990, 242 consecutive patients (75 men, 167 women; mean age 59.8+/-8.0 years; range: 32-77 years) underwent mitral valve replacement with the Xenomedica prosthesis. Preoperatively, patients were in NYHA classes III (66%) and IV (26%); 94 patients (39%) had undergone previous cardiac surgery and 201 (83%) had chronic atrial fibrillation. Etiology was rheumatic in 51%, myxomatous in 7%, ischemic in 1%, endocarditis in 2%, and due to dysfunction of a previously implanted device in 39%. In total, 115 (47%) patients underwent an associated procedure. Mean follow up was 142+/-24 months (range: 2-181 months); total follow up was 2,627 patient-years. RESULTS: Early mortality was 8.2% (14 patients with low-output syndrome, three with multi-organ failure, one with stroke and two with major bleeding, 2). Late mortality was 45% (3.8%/pt-year) (84 cardiac deaths, 38 being valve-related). Actuarial survival at 5, 10 and 15 years was 69+/-3%, 52+/-3% and 38+/-4%, respectively. Actuarial estimates of freedom from structural valve deterioration (SVD) at 5, 10 and 15 years were 93+/-2%, 64+/-4%, and 25+/-9%; in almost all cases SVD occurred in progressive fashion. At 5, 10 and 15 years, estimates of freedom from thromboembolism were respectively 90+/-2%, 83+/-3% and 83+/-3%, for anticoagulant-related hemorrhage 96+/-1%, 88+/-3% and 88+/-3%, for endocarditis 96+/-1%, 94+/-2% and 94+/-2%, and for reoperation 93+/-2%, 67+/-4% and 54+/-6%. Estimates of freedom from all valve-related mortality at 5, 10 and 15 years were 87+/-2%, 80+/-3% and 75+/-4%. Multivariate analysis (Cox model) showed younger age to be a significant risk factor for reoperation. CONCLUSION: Long-term results with the Xenomedica device implanted in the mitral position appear in line with those achieved for other first-generation bioprostheses. However, incidence of primary tissue failure within 10 years was unsatisfactory. Although sudden dysfunction of the device never occurred, close monitoring of survivors is warranted.

Experience with stentless aortic xenografts.

BACKGROUND AND AIM OF THE STUDY: The study aim was to define the long-term results after aortic valve replacement (AVR) with freehand stentless xenografts. METHODS: A retrospective analysis was performed of 376 consecutive patients (195 males, 181 females; mean age 70 +/- 7 years; range: 26-87 years) who underwent stentless AVR between October 1992 and April 2000. In total, 164 patients received Toronto SPV, 106 Biocor PSB, 101 Cryolife-O'Brien, and five other valves. Indication for surgery was valve stenosis (n = 246), regurgitation (n = 50), mixed lesion (n = 75) and prosthetic valve failure (n = 5). Mean preoperative NYHA functional class was 2.9 +/- 0.6 (range: 2-4). Associated procedures were required in 153 patients (41%), including coronary artery bypass grafting (n = 97), mitral operation (n = 26), ascending aortic replacement (n = 17) and 'other' (n = 13). Mean valve size was 25 +/- 3 mm (range: 21-29 mm), mean aortic cross-clamp time was 96 +/- 23 min (range: 42-186 min), and mean cardiopulmonary bypass time 128 +/- 34 min (range: 65-363 min). RESULTS: Ten patients (2.7%) died in hospital, due to cardiac causes (n = 6), cerebrovascular accident (n = 3) and multiorgan failure (n = 1). During a mean follow up of 40 +/- 20 months (range: 1-90 months) there were 33 late deaths. Survival was 96 +/- 1%, 83 +/- 3% and 80 +/- 4% and valve-related event-free survival 97 +/- 1%, 87 +/- 2% and 82 +/- 6% at one, five and seven years, respectively. Valve failure occurred in 21 (6%) patients (10 structural, nine non-structural, two endocarditis): freedom from structural valve deterioration was 99 +/- 1%, 95 +/- 2% and 92 +/- 4% at one, five and seven years. Reoperation on the xenograft was required in 17 (5%) patients, giving a freedom from reoperation of 99 +/- 1%, 94 +/- 2% and 90 +/- 4% at one, five and seven years. Freedom from valve failure and reoperation were significantly lower with Cryolife-O'Brien valves, but freedom from structural valve failure was similar. The average NYHA class was improved at follow up (1.4 +/- 0.7 versus 2.9 +/- 0.6 preoperatively, p = 0.01). CONCLUSION: Long-term survival and freedom from valve-related adverse events after stentless AVR in an elderly population were satisfactory. Freedom from structural deterioration was excellent and comparable for all xenograft models, while non-structural deterioration may have been more common with one valve model. Despite the advanced patient age, functional improvement late after operation may be expected.

Predicting long-term functional results after myocardial revascularization in ischemic cardiomyopathy.

OBJECTIVE: The goal of the present study was to define the early and late functional results after revascularization in ischemic cardiomyopathy and to identify variables predictive of a favorable outcome. METHODS: A retrospective review of all consecutive patients with ischemic cardiomyopathy undergoing myocardial revascularization between January 1991 and June 1998 was undertaken. One hundred sixty-seven patients (140 men) aged 60 +/- 8 years (range, 39-77 years) with angina (n = 107), congestive heart failure (n = 54), or silent ischemia (n = 6) were identified. One hundred six (63%) patients with angina were in Canadian Cardiovascular Society class III or IV, and 40 (24%) patients with congestive failure were in New York Heart Association class III or IV. The preoperative left ventricular ejection fraction averaged 0.28 +/- 0.05 (range, 0.16-0. 30). Thirteen (8%) patients required preoperative mechanical life support. A mean of 2.9 +/- 0.9 grafts per patient were performed, with an average myocardial ischemia time of 53 +/- 23 minutes and bypass time of 104 +/- 31 minutes. RESULTS: There were 3 (1.7%) early deaths and 21 (13%) deaths during follow-up (2.7 +/- 2.1 years; range, 0.3-7.8 years), producing a survival of 94% +/- 2% and 75% +/- 10% at 1 and 5 years, respectively. Despite a significant increase in left ventricular ejection fraction (0.28 +/- 0.05 vs 0. 38 +/- 0.09, P =.0001), only 89 (54%) patients were symptom-free at follow-up. Freedom from recurrent angina was 98% +/- 1% and 81% +/- 8%, whereas freedom from congestive failure was 78% +/- 11% and 47% +/- 20% at 1 and 5 years, respectively. Follow-up New York Heart Association class in patients with congestive failure was improved (40/54 class III-IV vs 11/54 class III-IV, P =.0001). Multivariate analysis showed a lower ejection fraction (P =.01), preoperative congestive failure (P =.03), and a need for preoperative intra-aortic balloon pumping (P =.03) to be associated with a greater prevalence of recurrent congestive failure, whereas male sex (P =.01), preoperative angina (P =.04), use of the internal thoracic artery (P =.03), and higher number of grafts (P =.01) were associated with lower prevalence. Male sex (P =.06), higher number of grafts (P =.04), and shorter duration of myocardial ischemia (P =. 04) were also predictive of improvement in New York Heart Association class at follow-up. CONCLUSIONS: Despite satisfactory early and late survival, late functional outcome after myocardial revascularization in ischemic cardiomyopathy remains suboptimal because of recurrence or persistence of congestive failure. Selection of appropriate surgical candidates and extensive use of complete revascularization with the internal thoracic artery may substantially improve functional results.

Predicting outcome after reoperative procedures on the aortic root and ascending aorta.

OBJECTIVE: Reoperations on the ascending aorta after prior aortic procedures are formidable challenges. In order to identify factors predictive of clinical outcome using a uniform surgical approach, results of a 15-year experience were reviewed. METHODS: Between 1983 and 1998, 78 reoperations on the ascending aorta were performed in 71 consecutive patients. There were 56 males and 15 females, aged 54+/-13 years (10-73 years), with a mean interval to first reoperation of 60+/-76 months (5-223 months). The original operation was replacement of ascending aorta (23), aortic valve (25), aortic root (7), ascending aorta with valve preservation (9), ascending aorta and aortic valve (7). Surgical approach included femoral vessels dissection and repeat sternotomy, with femoro-femoral bypass limited to cases of traumatic reentry. Reoperation consisted in replacement of the aortic root (48), ascending aorta (15), ascending aorta and aortic valve (6), aortic root with ascending aorta and arch (6), ascending aorta and aortic arch (3). Average aortic crossclamp and cardiopulmonary bypass times were 122+/-86 and 188+/-60 min, respectively. RESULTS: Early deaths were five (7%), due to low output syndrome (3), hemorrhage (1) and sepsis (1). Mortality for emergent reoperation was significantly higher (38 vs. 3%, P=0.001). A total of 39 early complications were observed in 78 reinterventions (50%), including: traumatic reentry requiring emergent femoro-femoral bypass (4), reexploration for bleeding (4), respiratory failure (12), sepsis (5), transient neurologic dysfunction (4), renal failure (3), myocardial infarction (3), circulatory insufficiency requiring mechanical life support (2), and wound infection (2). Average intensive care unit stay was 4.5+/-9.7 days (0.5-40 days). Survival was 92+/-4%, 78+/-10% and 78+/-10% at 1, 5, and 10 years, respectively. At follow-up (mean 34+/-36 months, 1-170), survivors were in satisfactory clinical conditions (1.6+/-0. 8 mean NYHA class, 1-3) with no evidence of renal, respiratory or neurologic dysfunction. Multivariable analysis showed emergent reoperation (P=0.001), prior aortic valve replacement (P=0.005) and need for arch replacement (P=0.03) to be predictive of higher operative mortality. Longer duration of bypass (P=0.01) and aortic arch replacement (P=0.04) were predictive of higher prevalence of postoperative complications. CONCLUSIONS: Reoperations on the ascending aorta via repeat sternotomy without preventive femoral bypass are associated with low operative risk and high prevalence early complications. Emergent reintervention due to aortic dissection, particularly in patients with prior aortic valve replacement, and need for arch repair are predictive of poorer perioperative outcome. Long-term outlook of hospital survivors is satisfactory.

[State of the art: low-molecular-weight heparin and beyond]. / Stato dell'arte: eparine a basso peso molecolare ed oltre.

Approximately 20 years ago a new family of antithrombotic compounds started to be investigated: the low-molecular weight heparins (LMWH). The rationale for their use was based on the evidence that the inhibition of the Factor Xa of blood coagulation was less marked than that of Factor IIa when using the LMWHs as compared to unfractioned heparin (HF). This particular mechanism of action was considered to be of advantage regarding the safety profile (the pro-haemorrhagic effect) compared to HF. Today we know that the real advantage of LMWHs is due to their high bioavailability which makes safe and reliable their subcutaneous administration without laboratory monitoring. The LMWHs are equally effective than HF for the treatment of acute Deep Vein Thrombosis. For the prophylaxis of Venous Thromboembolism, LMWHs are indicated as first choice in high-risk patients such as those undergoing major orthopaedic surgery. The future development of this family of drugs encompasses the launch of the pentasaccharide which is a pure anti-/Xa inhibitor.

Blood versus crystalloid cardioplegia for myocardial protection of donor hearts during transplantation: A prospective, randomized clinical trial.

OBJECTIVE: To assess the safety and efficacy of myocardial protection of the donor heart during transplantation with the use of blood cardioplegia, a prospective randomized clinical trial was undertaken between January 1997 and March 1998. METHODS: Forty-seven consecutive patients were assigned either to crystalloid (27 patients; group 1) or blood cardioplegia (20 patients; group 2). Comparison of recipient age (54 +/- 11 years vs 55 +/- 7 years; P =. 9), sex (89% vs 90% male patients; P =.9), diagnosis (63% vs 65% dilated cardiomyopathy; P =.8), elevated pulmonary vascular resistance (30% vs 30%; P =.9), prior cardiac operations (22% vs 30%; P =.5), need for urgent heart transplantation (7% vs 20%; P =. 2), donor age (32 +/- 11 years vs 31 +/- 13 years; P =.7), cause of death (33% vs 40% vascular; P =.5), and global myocardial ischemia (176 +/- 51 minutes vs 180 +/- 58 minutes; P =.5) showed no difference. Hemodynamically unstable donors (15% vs 45%; P =.02) were more prevalent in group 2. RESULTS: Operative mortality rates (4% vs 5%; P =.8), high-dose inotropic support (41% vs 30%; P = 0.6), and postoperative mechanical assistance (11% vs 10%; P = 0.9) were comparable in the 2 groups. Prevalence of acute right heart failure (27% vs 0; P =.02) and of temporary complete atrioventricular block (52% vs 20%; P =.02) were greater in group 1. Spontaneous sinus rhythm recovery was more prevalent in group 2 (11% vs 40%; P =.02). Higher peak creatine kinase (1429 +/- 725 u/L vs 868 +/- 466 u/L; P =.01) and creatine kinase MB (144 +/- 90 u/L vs 102 +/- 59 u/L; P =. 06) levels suggested more severe ischemic injury in group I. CONCLUSION: Use of blood cardioplegia was associated with a lower prevalence of right heart failure, cardiac rhythm dysfunction, and laboratory evidence of ischemia.

Mid-term results after heart valve replacement with the CarboMedics bileaflet prosthesis: experience with 785 implants.

BACKGROUND: The aim of the study was to evaluate our clinical experience with the CarboMedics Heart Valve Prosthesis. METHODS: Between October 1991 and December 1997, six hundred seventy-two consecutive patients (361 men, 54%; 311 women, 46%; mean age 57 +/- 12 year, range 6-73 years) underwent mechanical valve implantation at the Division of Cardiac Surgery of the University of Verona. Preoperatively, 69% of the patients were in NYHA FC III or IV. Eighty-one patients (12%) had undergone a previous cardiac operation and 14.5% had an ejection fraction less than 35%. We performed an aortic valve replacement in 309 patients (78 valved-conduits for replacement of the entire aortic root), a mitral valve replacement in 250, and a double valve in 113. 52 patients (8%) underwent associated myocardial revascularization. RESULTS: Early mortality was 2.8% (5/309 aortic, 1.6%; 11/250 mitral, 4.4%; 3/113 double, 2.6%). Late mortality was 4.4%. Actuarial survival at 5 years was 89.3% (aortic, 91.1%, mitral 86.4%, double 90.5%). Thromboembolism occurred in 26 patients (3.9%) and major hemorrhagic events in 20 (3%). Nine patients (1.3%) required a reoperation, in 3 cases (0.4%) after endocarditis (Staphylococcus epidermidis). No structural deterioration occurred in our series. CONCLUSION: Our study appears to confirm the safety and reliability of the CarboMedics mechanical valve prosthesis, even in old age groups. This bileaflet prosthesis demonstrates no structural deterioration, a low incidence of complications, and good hemodynamic performance.

Recurrence of aortic insufficiency after aortic root remodeling with valve preservation.

BACKGROUND: Aortic root remodeling (ARR) has recently been proposed for patients with aortic aneurysms and valve insufficiency (AI). To define factors associated with a favorable functional outcome, a review of the mid-term results with ARR was undertaken. METHODS: Between March 1994 and October 1997, 17 consecutive patients (11 men, 6 women), aged 57 +/- 11 years (range 35-71), had elective ARR for aortic aneurysm with or without annuloaortic ectasia (13), sinus of Valsalva aneurysm (3), or chronic aortic dissection (1). Moderate or severe AI was present in 11 patients (65%). Preoperative aortic root diameter was 58 +/- 5 mm (range 51-70). ARR involved replacement of all three aortic sinuses and coronary button reimplantation, using grafts with a mean diameter of 28 +/- 2 mm (range 24-30). RESULTS: There was one early death (6%) due to multiple organ failure. Survivors were followed for 16 +/- 12 months (range 1-44). Actuarial 3-year survival was 94% +/- 6%. Discharge echocardiogram showed a decrease in AI in all patients: AI was absent in 11 (69%) and mild in 5 (31%). Recurrence of moderate or severe AI after a mean of 16 +/- 9 months (range 9-28) was noted in 6 patients (37%), 3 of whom had no AI at discharge. Five of 6 patients required aortic valve replacement. Comparison of demographic and operative variables showed that severe preoperative AI (67% vs 20%, p = 0.06), annuloaortic ectasia (100% vs 20%, p = 0.002), and cystic medial necrosis (100% vs 20%, p = 0.002) were significantly more prevalent in patients developing severe AI at follow-up. The 10 patients (63%) with absent AI showed durable competence of the valve and relief from symptoms at follow-up. CONCLUSIONS: Despite early restoration of valve competence, AI may recur and progress after ARR at medium-term follow-up in a proportion of patients. The severity of preoperative AI and the nature of aortic root disease may negatively influence the durability of repair. Continued observation of results with ARR appears mandatory to identify the appropriate surgical candidates.

Aortic root replacement with the Carboseal composite graft: 7-year experience with the first 100 implants.

BACKGROUND: Aortic root replacement remains a challenging surgical procedure. A variety of techniques and prosthetic devices have thus far been used. In order to assess the performance of the Carboseal (Sultzer Carbomedics, Inc, Austin TX) composite graft, review of the experience with composite root replacement was undertaken. METHODS: Between January 1979 and December 1998, 273 patients underwent composite aortic root replacement. One-hundred-six received the Carboseal composite prosthesis (group 1) and 84 other types of composite grafts (group 2). Demographic and operative variables were similar in the 2 patient groups, except for an older mean age in group 1 (58+/-12 versus 50+/-12 years, p = 0.001). RESULTS: Operative mortality was lower in group 1 patients (3 of 106, 3% versus 10 of 84, 12%, p = 0.04). Follow-up of survivors was longer in group 2 due to more recent adoption of the Carboseal grafts (93+/-57 versus 36+/-23 months, p = 0.01). Late mortality was higher in group 2 (3 of 103, 3% versus 13 of 74, 18%, p = 0.04), with higher prevalence of prosthetic-related complications (2 of 103, 2% versus 12 of 74, 15%, p = 0.002). Reoperation was more prevalent in group 2 (1 of 103, 1% versus 5 of 74, 8%, p = 0.04), and limited to patients having root replacement using the inclusion technique. Functional status of survivors was comparable in the 2 groups (83 of 103, 80% versus 45 of 74, 61% of patients in New York Heart Association class I, p = 0.1). CONCLUSIONS: Aortic root replacement using the Carboseal composite graft offers excellent long-term results, with negligible prevalence of prosthetic-related complications. Superior performance compared to other available composite grafts in the present series may be influenced by more recent adoption of the Carboseal conduit and concomitant uniform adoption of coronary button technique.

Risk factors for coronary complications after stentless aortic root replacement.

Coronary complications after aortic root replacement (ARR) with pulmonary autografts have been reported to be more common than with other stentless biological conduits (homografts, xenografts). To verify this hypothesis, results with 84 consecutive patients having stentless ARR between January 1992 and January 1999 were reviewed. Fifty patients had autograft (Group 1) and 34 either homograft or xenograft (Group 2) ARR. Comparison of age (27+/-9 vs. 38+/-22 years, P = ns), prevalence of male sex (86% vs. 79%, P = ns), aortic root disease (30% vs. 44%, P = ns), congenital coronary anomalies (10% vs. 3%, P = ns), prior aortic procedure (16% vs. 15%), and need for associated procedures (26% vs. 24%, P = ns), did not disclose significant differences. Bicuspid aortic valve was more prevalent in Group 1 (56% vs. 9%, P = .001). Mean aortic crossclamp (154+/-28 vs. 120+/-24 minutes, P = .05) and bypass (216+/-30 vs. 192+/-58 minutes, P = .05) times were longer in Group 1. Early mortality was comparable (2% vs. 3%, P = ns) and caused by right ventricular ischemia in both groups. Overall prevalence of coronary complications was higher in Group 1 (10% vs. 3%, P = .04), all resulting in right heart ischemia. Intraoperative partial takedown of repair in 5 Group 1 patients, associated with CABG in 1, resulted in prompt resolution of myocardial ischemia in 4 (80%) and prolonged in 1, which ultimately died as a result of sepsis. Recovery was prompt in all 4 patients (mean ICU stay 35+/-28 hours) with no metabolic or echocardiographic evidence of myocardial infarction. At discharge echocardiography, satisfactory biventricular kinetics was found in all patients. Analysis of preoperative variables showed bicuspid aortic valve (83% vs. 33%, P = .01) and coronary anomalies (67% vs. 3%, P = .001) to be more prevalent in patients suffering from coronary complications. Stentless ARR is a safe procedure with low operative mortality, regardless of the type of biological conduit. Autograft ARR may be at greater risk of right ventricular ischemia in patients with bicuspid aortic valve and coronary anomalies. An aggressive intraoperative approach including partial takedown of repair may limit the morbidity of coronary complications.

Stentless aortic xenograft valve replacement: lessons learned after 300 implants.

Early results after aortic valve replacement (AVR) with three different types of stentless xenografts suggested less satisfactory outcome with a simplified implant model (Cryolife-O'Brien) compared with two standard implant models (Biocor PSB, Toronto SPV). To assess the impact of experience on mid-term outcome after stentless AVR, results with 322 implants were reviewed. Between July 1992 and February 1999, 106 patients underwent operations to implant the Biocor PSB (group 1), 139 patients the Toronto SPV (group 2), and 77 patients the Cryolife-O'Brien valve (group 3). Mean age (70+/-6 years; 70+/-7 years; 71+/-7 years; P = .7), prevalence of male gender (56 patients, 53%; 72 patients, 55%; 38 patients, 49%; P = .4), prevalence of aortic stenosis (72 patients, 68%; 77 patients, 55%; 38 patients, 49%; P = .7), and need for associated procedures (51 patients, 48%; 54 patients, 39%; 33 patients, 43%; P = .7) were similar among all three groups, respectively. Mean aortic cross-clamp time was shorter in group 3 (96+/-24 min; 98+/-24 min; 78+/-22 min; P = .02). Early deaths (3/106, 3%; 4/139, 3%; 2/77; 3%, P = .8) and late survival were comparable (89%+/-5%, 93%+/-4%, and 85%+/-7% at 5 years, P = .1) among groups. Follow-up ranged from 1 to 84 months (mean 52+/-20 months). Five-year freedom from valve deterioration (95%+/-5%, 96%+/-3%, and 85%+/-7%, P = .008) and from reoperation (98%+/-2%, 98%+/-2%, 92%+/-4%, P = .01) was significantly poorer in group 3 patients. When valve failure resulting from technical mishaps (none in the last 60 implants) with the Cryolife-O'Brien valve was excluded, no significant difference in freedom from valve deterioration was noted (98%+/-2%, 96%+/-3%, and 95%+/-4%, P = .1). Late functional status of 290 survivors was satisfactory and comparable among groups (1.3+/-0.8, 1.1+/-0.4, and 1.4+/-0.7 New York Heart Association class, P = .5). After an initial learning curve, simplified implant stentless xenografts offer satisfactory mid-term results, which are comparable to two-suture-line implant valves. Owing to the shorter grafting time, simplified implant xenografts such as the Cryolife-O'Brien may be particularly suited for complex operations where associated procedures are required.

Aortic root replacement: twenty years of experience.

BACKGROUND: Aortic root replacement is a complex surgical procedure which has undergone major technical modifications with time. In order to assess the early and long-term outcome after aortic root replacement with this procedure, our entire experience of a two decade period was reviewed. METHODS: Between January 1979 and March 1997, 156 aortic root replacement operations were performed. One hundred and twenty five patients (80%) were male and 31 female; their mean age was 50 +/- 16 years. Diagnosis was annuloaortic ectasia in 79 patients, aortic dissection in 51 (acute 22, chronic 29), isolated aortic valve pathology in 24 and aneurysm of sinus of Valsalva in 5. Thirty nine patients had aortic root replacement using the standard "Bentall" technique, 73 using the "modified Bentall" technique, 15 using the Cabrol technique. Biologic substitutes of the aortic root were used in 29 patients (19 autografts, 4 homografts, 6 xenografts). Mean follow-up time was 41 +/- 40 months (range 1 month-18 years). RESULTS: There were 12 (7.6%) hospital deaths. Hospital mortality in elective cases was 5% (7/134) and 22% (5/22) in emergent (p = 0.01). A trend toward reduced early mortality was demonstrated in recent years. Mortality was 5% for the "modified Bentall" group, 3% for the "Biologic root" group, 10% for the "Bentall" group and 20% for the "Cabrol" group. Hospital mortality was significant higher in "Cabrol" group than in "modified Bentall" group (p = 0.04). The overall long-term survival rate was 78 +/- 4% at 5 years, 71 +/- 6% at 10 years and 51 +/- 13% at 15 years. No significant difference in survival rate nor freedom from complications was observed among patient groups. Need for reoperation and valve-related adverse events become prevalent after 10 years of follow-up. CONCLUSION: The decrease in early mortality and the satisfying late results demonstrate that aortic root replacement is a low risk surgical procedure and an effective and durable treatment. The availability of biologic substitutes for the aortic root has allowed the extension of this operation to all patient age group, with results comparable to these obtained with composite grafts.

Functional outcome after myocardial revascularization in ischemic left ventricular failure.

BACKGROUND: Myocardial revascularization in patients with left ventricular failure (ejection fraction < 30%) offers survival comparable to heart transplantation. The functional outcome, however, has yet to be determined. In order to assess the clinical results in patients with LVEF < 30% undergoing coronary artery bypass grafts (CABG), 101 consecutive patients operated between 1/91 and 1/97 were reviewed retrospectively. METHODS: The patients were stratified according to presentation: 65 pts had angina (Group 1) and 36 congestive failure (Group 2). Mean age (62 +/- 7 vs 60 +/- 8 yrs), sex (90 vs 88% male), LVEF (0.28 +/- 0.04 vs 0.29 +/- 0.04), prior myocardial infarction (1.2 +/- 0.4 vs 1.2 +/- 0.5 episodes/pt), presence of vital myocardium at scintiscan or low-dose dobutamine echocardiography (92 vs 93%), need for preoperative IABP (3.1 vs 8.3%), aortic cross-clamp (53 +/- 21 vs 60 +/- 21 min) and cardiopulmonary bypass (104 +/- 31 vs 114 +/- 36 min) times were comparable. RESULTS: There was only 1 (1%) perioperative death due to low-output syndrome. Eleven pts (6 vs 5, Group 1 vs Group 2) had postoperative low-output syndrome, requiring IABP in 7 pts (4 vs 3). There were 14 (10 vs 4, Group 1 vs Group 2) deaths during follow-up (29 +/- 19 months, range 2-67), with an overall actuarial survival of 91 +/- 4 vs 100% at 1 yr and 74 +/- 9 vs 78 +/- 10% at 5 yrs in Group 1 vs Group 2, respectively (p = ns). Actuarial symptom-free survival was 89 +/- 4 vs 84 +/- 6% at 1 yr and 49 +/- 9 vs 28 +/- 11% at 5 yrs, respectively (p = 0.05). Despite the high recurrence of congestive failure (22 vs 66% in Group 1 vs Group 2, p = 0.004), improvement in functional class (3.1 +/- 0.8 vs 1.5 +/- 0.7 in Group 1 and 2.7 +/- 0.7 vs 1.8 +/- 0.5 in Group 2) and LVEF (0.28 +/- 0.04 vs 0.38 +/- 0.04 in Group 1 and 0.29 +/- 0.04 vs 0.40 +/- 0.06 in Group 2) was found in both groups at follow-up. CONCLUSIONS: In spite of improving early and late survival after revascularization for ischemic left ventricular failure, patients presenting with congestive failure have an unsatisfactory symptom-free survival. Further studies are necessary to ascertain the relative indications to revascularization or transplantation in this specific patient subgroup.

Stanford type A aortic dissection. A new surgical approach.

We describe a new surgical technique adopted for the repair of Stanford type A aortic dissection. In order to minimize the risk of malperfusion caused by retrograde flow during cardiopulmonary bypass, we avoid femoral artery cannulation. On the hypothesis that it is best not to interfere with the hemodynamics of the dissection, we cannulate the dissected ascending aorta, in either the true or false lumen. We here report 2 cases of successful surgical treatment of Stanford type A aortic dissection. In both cases, the false lumen was cannulated under deep hypothermic circulatory arrest, without clamping the aorta. While the patient was cooling, a 10-mm GORE-TEX side arm was sutured to a Dacron graft prosthesis. Repair of the aortic arch was carried out 1st. The aortic cannula was inserted into the GORE-TEX side arm, the tubular prosthesis was cross-clamped, and cardiopulmonary bypass was reinstituted. After this, the aortic bulb was repaired as usual and the tubular prosthesis was sutured to the bulb. No postoperative cerebral complication occurred. Our experience must be confirmed by more cases and a longer follow up.