A New Device for Securing Sternal Wires After Median Sternotomy: Biomechanical Study and Retrospective Clinical Assessment.

OBJECTIVE: Morbidity due to sternotomy continues to be a significant clinical problem. Poor approximation of the sternum may lead to complications such as sternal dehiscence, infection, and pain. A device to assist in tensioning and twisting standard steel wires during sternal closure has been developed (TORQ sternal closure device). Manually tightened interrupted wire closures were compared with those tightened and secured with the aid of the device. Performance of the device was assessed clinically. METHODS: Four cardiovascular surgeons performed manual and device-assisted closures on a biofidelic model. Closure force was measured to determine the residual force and its intraoperator variation. A retrospective review of patients treated before and after the introduction of the device was conducted. Predicted and actual outcomes were compared for the two groups (manual closure and device-assisted closure). RESULTS: Biomechanical testing measured a 75% increase in residual closure force (P < 0.001) and a significant reduction in the variability of the closure force (P = 0.045) for device-assisted closures compared with manual closures. In the retrospective study, 3 of 173 manually closed patients had sterile sternal dehiscence and 1 of 173 had a deep sternal wound infection. In the device closure group, 2 of 127 had a sterile sternal dehiscence and no deep sternal wound infections were reported. No other device-related serious adverse events were reported. CONCLUSIONS: Biomechanical data showed stronger, more consistent closure forces with the device. The retrospective data attest to the performance of the device.

Prolonged QTc affects short-term and long-term outcomes in patients with normal left ventricular function undergoing cardiac surgery.

OBJECTIVE: Although it is known that preoperative decreased left ventricular ejection fraction (LVEF) is a risk for morbidity and mortality after cardiac surgery, there are no reliable markers of risk in patients with preserved LVEF. This study examines whether a prolonged QTc interval is associated with adverse outcomes in patients with preoperative LVEF greater than 40% undergoing cardiac surgery. METHODS: A retrospective chart review of patients who had cardiac surgery at St. Paul's Hospital in Vancouver, Canada, between 2004 and 2009, who had a preoperative LVEF greater than 40%, was undertaken. We tested for association of preoperative prolonged QTc interval with mortality and morbidity using unadjusted and adjusted analyses. RESULTS: Five-hundred and fifty-five patients with a preoperative LVEF greater than 40% were included in the study; 496 (89.4%) had cardiopulmonary bypass and the remainder were off pump. Preoperative prolonged QTc was associated with increased mortality at 30 days (P < .01), 90 days (P < .01), and 8 years (P < .01), and these results remained significant after adjusting for the clinical variables significantly associated with mortality (8-year odds ratio, 2.42; 95% confidence interval, 1.34-4.34; P = .003). Similar results were found when the analysis was restricted to the more homogeneous group of patients undergoing on-pump coronary artery bypass (CABG, n = 408). Prolonged QTc was also associated with prolonged intensive care unit stay (P = .02), prolonged hospital stay (P < .01), development of atrial arrhythmias (P = .02), and low cardiac output syndrome (on-pump CABG, P = .02). CONCLUSIONS: In patients undergoing cardiac surgery and a preoperative LVEF greater than 40%, a prolonged QTc interval is associated with increased short-term and long-term mortality and increased perioperative morbidity, and therefore should be considered when assessing risk preoperatively.

Transapical transcatheter aortic valve-in-valve implantation: clinical and hemodynamic outcomes beyond 2 years.

OBJECTIVE: The feasibility of transapical valve-in-valve aortic valve implantation into a failed aortic surgical bioprosthesis has been confirmed. The purpose of the present study was to investigate the clinical and hemodynamic outcomes more than 2 years after transapical valve-in-valve aortic valve implantation. METHODS: From April 2007 to May 2010, 8 consecutive patients underwent transapical valve-in-valve aortic valve implantation of either 23- or 26-mm Edwards-SAPIEN balloon-expandable bioprostheses into failed surgical tissue valves (21- to 25-mm valves). Clinical and echocardiographic follow-up was performed in all patients. The mean follow-up duration was 27.8 ± 15.7 months (range, 18-55 months). RESULTS: Transapical valve-in-valve aortic valve implantation was successful in all patients (mean age, 84.1 ± 1.6 years). The predicted operative mortality was 42.1% ± 15.7% by logistic European System for Cardiac Operative Risk Evaluation and 14.4% ± 9.6% using the Society of Thoracic Surgeons risk calculator. The observed 30-day mortality was 12.5%. No strokes or valve embolization/migrations occurred. The mean hospital stay was 9.0 ± 9.1 days. The New York Heart Association class decreased from preoperative class III-IV to postoperative class I in 6 of 7 survivors. The 2-year survival was 87.5%. No late mortality occurred during the follow-up period. The echocardiographic results at 1 to 4 years of follow-up demonstrated stable valve position and function in all patients. The transaortic valve pressure gradients after valve-in-valve aortic valve implantation were greater than 20 mm Hg and less than 15 mm Hg in patients with 21- or 23-mm and 25-mm surgical valves, respectively. CONCLUSIONS: Transapical valve-in-valve aortic valve implantation provides good clinical outcomes and stable valve function beyond 2 years of follow-up. The best hemodynamic and clinical outcomes can be achieved in the patients with a surgical valve size of 25 mm or greater. Valve-in-valve aortic valve implantation could become a viable approach for selected high-risk patients with failed surgical bioprostheses.

Long-term outcomes after transcatheter aortic valve implantation: insights on prognostic factors and valve durability from the Canadian multicenter experience.

OBJECTIVES: This study sought to evaluate the long-term outcomes after transcatheter aortic valve implantation (TAVI) in the Multicenter Canadian Experience study, with special focus on the causes and predictors of late mortality and valve durability. BACKGROUND: Very few data exist on the long-term outcomes associated with TAVI. METHODS: This was a multicenter study including 339 patients considered to be nonoperable or at very high surgical risk (mean age: 81 ± 8 years; Society of Thoracic Surgeons score: 9.8 ± 6.4%) who underwent TAVI with a balloon-expandable Edwards valve (transfemoral: 48%, transapical: 52%). Follow-up was available in 99% of the patients, and serial echocardiographic exams were evaluated in a central echocardiography core laboratory. RESULTS: At a mean follow-up of 42 ± 15 months 188 patients (55.5%) had died. The causes of late death (152 patients) were noncardiac (59.2%), cardiac (23.0%), and unknown (17.8%). The predictors of late mortality were chronic obstructive pulmonary disease (hazard ratio [HR]: 2.18, 95% confidence interval [CI]: 1.53 to 3.11), chronic kidney disease (HR: 1.08 for each decrease of 10 ml/min in estimated glomerular filtration rate, 95% CI: 1.01 to 1.19), chronic atrial fibrillation (HR: 1.44, 95% CI: 1.02 to 2.03), and frailty (HR: 1.52, 95% CI: 1.07 to 2.17). A mild nonclinically significant decrease in valve area occurred at 2-year follow-up (p < 0.01), but no further reduction in valve area was observed up to 4-year follow-up. No changes in residual aortic regurgitation and no cases of structural valve failure were observed during the follow-up period. CONCLUSIONS: Approximately one-half of the patients who underwent TAVI because of a high or prohibitive surgical risk profile had died at a mean follow-up of 3.5 years. Late mortality was due to noncardiac comorbidities in more than one-half of patients. No clinically significant deterioration in valve function was observed throughout the follow-up period.

Conventional aortic valve replacement remains a safe option in patients aged > or = 70 years: a 20-year experience.

BACKGROUND AND AIM OF THE STUDY: Increased life expectancy has resulted in the elderly frequently presenting with severe aortic stenosis. It has therefore become important to define indications for conventional aortic valve replacement (AVR) and transcatheter aortic valve implantation (TAVI) in this patient population. Thus, patients aged > or = 70 years undergoing conventional isolated AVR were evaluated for predictors of early and late mortality. METHODS: A retrospective analysis was conducted of prospectively collected data available from 1,061 consecutive patients (age range: 70-94 years) who underwent isolated AVR between 1982 and 2002. The patient age groups were 70-74 years (n = 466), 75-79 years (n = 367), and > or = 80 years (n = 228). The mean follow up was 6.0 +/- 4.4 years, and the total follow up 6,390 patient-years. Twenty-two variables were considered as potential risk factors for early and late mortality. RESULTS: Early mortality was higher in patients aged > or = 80 years than in those aged 70-79 years. Early mortality in patients aged > or = 80 years was lower between 1998 and 2002 than between 1982 and 1997. Multivariate predictors of early mortality were age > or = 80 years, operative status, previous intervention, renal failure, and mitral regurgitation. The early nonfatal complication rate was similar for patients aged 70-79 years and > or = 80 years, but late mortality was lower between 1998 and 2002 than between 1982 and 1997 in patients aged 70-79 years, and in those aged > or = 80 years. The 10-year actuarial survivals after AVR in patients aged 70-74, 75-79, and > or = 80 years were 54 +/- 3.0%, 43 +/- 3.8% and 17 +/- 3.9%, respectively. Multivariate predictors of late mortality were age 75-79 years, age > or = 80 years, peripheral vascular disease (PVD) and chronic obstructive pulmonary disease (COPD). Female gender was shown to be protective. CONCLUSION: Early mortality was higher in patients aged > or = 80 years undergoing AVR, though this has declined recently and is currently at an acceptable level. Other important predictors of mortality in elderly patients undergoing AVR are operative status, previous interventions, renal failure, mitral regurgitation, male gender, PVD, and COPD. Thus, conventional AVR remains a safe treatment option for the elderly patient.

Pathology of transcatheter valve therapy.

OBJECTIVES: This study sought to report on the pathology of transcatheter aortic valves explanted at early and late time points after transcatheter aortic valve implantation. BACKGROUND: Information on pathological findings following transcatheter aortic valve implantation is scarce, particularly late after transcatheter aortic valve implantation. METHODS: This study included 20 patients (13 men, median age 80 years [interquartile range: 72 to 84] years) with previous transcatheter aortic valve implantation with a valve explanted at autopsy (n = 17) or surgery (n = 3) up to 30 months after implantation (10 transapical and 10 transfemoral procedures). RESULTS: Structural valve degeneration was not seen, although fibrous tissue ingrowth was observed at later time points with minimal effects on cusp mobility in 1 case. Minor alterations in valve configuration or placement were observed in up to 50% of cases, but they were not accompanied by substantial changes in valve function or reliably associated with chest compressions. Vascular or myocardial injury was common, especially within 30 days of transcatheter aortic valve implantation (about 69%), with the latter associated with left coronary ostial occlusion by calcified native aortic valve tissue in 2 cases. Mild to severe myocardial amyloidosis was present in nearly 33% of cases and likely played a role in the poor outcome of 3 patients. Endocarditis, migration of the valve, and embolization during the procedure led to surgical valve removal. CONCLUSIONS: Structural degeneration was not seen and minor alterations of valve configuration or placement did not affect valve function and were not reliably caused by chest compressions. Vascular or myocardial injury is very common early after transcatheter aortic valve implantation and myocardial amyloidosis represents a relatively frequent potentially significant comorbid condition.

A high-risk period for cerebrovascular events exists after transcatheter aortic valve implantation.

OBJECTIVES: This study assesses if there exists a high-risk period for cerebrovascular events (CeV) after transcatheter aortic valve implantation (TAVI). BACKGROUND: Even though acute strokes after TAVI have been described, it is uncertain if stroke rates continue to remain high in the early months after TAVI. Furthermore, the optimal dose and duration of thromboprophylaxis is unclear. METHODS: Patients who underwent TAVI were evaluated at baseline, at discharge, at 1 and 6 months, and yearly. Risk factors for CeV events, procedural details, and antithrombotic therapy were recorded. Outcomes assessed were CeV events and death. The timing of such events, predictors, and impact on survival were analyzed. RESULTS: A total of 253 patients were assessed. Median age was 85 years. The median Society of Thoracic Surgeons score was 8.1% (interquartile range [IQR]: 5.5% to 12.0%). Risk factors included smoking (47%), hypertension (70%), dyslipidemia (66%), and diabetes mellitus (25%). Twenty-three percent had known cerebrovascular disease and 39% had atrial fibrillation. Median follow-up was 455 days (IQR: 160 to 912 days) at which time 23 patients experienced a CeV event. The incidence was highest in the first 24 h but remained high for 2 months. In-hospital mortality rate after a CeV event was 21%. A prior history of CeV disease was an independent predictor of an event (hazard ratio: 4.23, 95% CI: 1.60 to 11.11, p = 0.004). CONCLUSIONS: The incidence of CeV events is highest within 24 h of TAVI, but this risk may remain elevated for up to 2 months. A prior history of cerebrovascular disease is an independent predictor. This may have implications for patient selection and antithrombotic strategies.

Transapical transcatheter aortic valve implantation in the presence of a mitral prosthesis.

OBJECTIVES: We review our experience with transapical transcatheter aortic valve implantation (AVI) in patients with functioning mitral prostheses, and describe the technical considerations. BACKGROUND: Transcatheter AVI for aortic stenosis in patients with mitral prostheses is technically challenging. METHODS: Ten patients (7 mechanical and 3 bioprosthetic mitral valves) received the Edwards SAPIEN balloon-expandable valve (Edwards Lifesciences, Irvine, California) during 2006 to 2010. All patients were declined conventional surgery and prospectively followed. The mean patient age was 77.6 ± 7.1 years (range: 67 to 88 years). The logistic EuroSCORE and the Society of Thoracic Surgeons-predicted operative mortality were 30.3 ± 18.6% (range: 11.4% to 70.4%), and 9.9 ± 4.8% (range: 4.6% to 18.7%), respectively. RESULTS: All valves were successfully implanted, with no 30-day mortality or mitral prosthetic dysfunction. Nine patients had none to mild residual aortic paravalvular leak. The overall survival was 60% at a mean follow-up of 12.2 ± 10.4 months (range: 2 to 33 months), with 4 nonvalve-related deaths. Seven patients improved to New York Heart Association functional class I to II. The mean transvalvular gradient and effective orifice area improved from 40.0 ± 17.4 mm Hg to 8.2 ± 2.1 mm Hg, and 0.6 ± 0.1 cm² to 1.3 ± 0.2 cm², respectively (p < 0.0001). The mitral bioprosthetic strut predisposes to device "shift" during deployment. An "unfavorable" mechanical mitral prosthetic cage or pivot strut can also cause shifts. Balloon shifts during valvuloplasty warn of a high likelihood of prosthesis shift. CONCLUSIONS: This report details the technical lessons learned thus far from our first 10 patients. Excellent procedural success and early outcomes in patients with functioning mitral prosthesis can be achieved.

Early clinical outcomes after transapical aortic valve implantation: a propensity-matched comparison with conventional aortic valve replacement.

OBJECTIVE: Aortic valve replacement remains the standard treatment for symptomatic severe aortic stenosis. However, catheter-based approaches have recently emerged as therapeutic options for high-risk surgical candidates. The objective of this study is to use propensity scoring to compare early clinical outcomes after transapical aortic valve implantation and conventional aortic valve replacement. METHOD: Propensity scoring based on logistic regression modeling of 16 preoperative patient characteristics was used to identify a group of very high-risk patients undergoing isolated conventional aortic valve replacement comparable to those patients undergoing transapical aortic valve implantation. McNemar's test was used to compare early clinical outcomes between the 2 treatment groups, including 30-day mortality and in-hospital postoperative complications. RESULTS: Ninety-two patients receiving transapical aortic valve implantation between October 2005 and April 2010 met inclusion criteria for this study. Half of these patients were successfully matched 1:1 to a patient receiving conventional aortic valve replacement. Baseline characteristics were similar between the 2 treatment groups after propensity matching. There were 4 perioperative deaths (8.7%) in the conventional aortic valve replacement group and 6 perioperative deaths (13%) in the transapical aortic valve implantation group (P > .05). There were no significant differences in the rates of cerebrovascular accidents, wound infections, reoperation for bleeding, or length of postoperative hospital stay between the 2 groups (P > .05). CONCLUSIONS: Among high-risk propensity-matched patients, early clinical outcomes are similar after transapical aortic valve implantation and conventional aortic valve replacement. However, given the likelihood of residual selection bias, a prospective randomized trial is necessary to adequately compare the clinical outcomes after these 2 aortic valve procedures.

Outcome of patients after transcatheter aortic valve embolization.

OBJECTIVES: This study aims to assess the mid- to long-term follow-up of patients after valve embolization at the time of transcatheter aortic valve implantation (TAVI). BACKGROUND: Transcatheter heart valve (THV) embolization is a rare but serious complication during TAVI. Although various techniques have been developed to manage acute complications and reduce periprocedural morbidity/mortality, long-term clinical and hemodynamic consequences after these events are unknown. METHODS: Patients who developed THV embolization after TAVI were prospectively assessed. Clinical and echocardiographic characteristics were recorded at baseline and after successful TAVI/surgical aortic valve replacement. The THV migration and strut fractures/degeneration were assessed by computed tomography. RESULTS: A total of 7 patients had THV embolization, all of which occurred immediately after valve deployment. The embolized THV was repositioned in the aortic arch proximal to the left subclavian artery (n = 2), immediately distal to the left subclavian artery (n = 2), and in the abdominal aorta (n = 3). A second THV was implanted successfully at the same sitting in 4 patients and at the time of a second procedure in 2 patients. Elective conventional aortic valve replacement was performed in 1 patient. Median follow-up was 1,085 days. One patient died during follow-up from an unrelated cause. The remaining 6 survivors were in New York Heart Association functional class I or II at final follow-up. Mid-term computed tomography follow-up (n = 4,591 to 1,548 days) showed that the leaflets of the embolized THV remain open in all phases of the cardiac cycle. There was also no strut fracture or migration of these valves. CONCLUSIONS: Clinical outcomes remain good when THV embolization is managed effectively. There are no apparent hemodynamic consequences of a second valve placed in the series. These embolized valves remain in a stable position with no evidence of strut fractures at mid-term follow-up.

Transcatheter transapical mitral valve-in-valve implantations for a failed bioprosthesis: a case series.

OBJECTIVES: Mitral valve replacement with bioprosthetic valves is becoming more common. The incidence of structural valve deterioration and the need for reoperative mitral surgery are expected to increase. The operative mortality and morbidity associated with redo mitral surgery remains high. Transapical transcatheter mitral valve-in-valve implantation might offer an alternate and safer approach for high-risk patients. METHODS: From July 2007 to April 2010, 11 patients with symptomatic mitral prosthetic valve dysfunction underwent transapical transapical transcatheter mitral valve-in-valve implantation in our institution. Data were collected and entered into a database prospectively. The mean age was 81 ± 5 years, with 64% being female. The mean Society of Thoracic Surgeons risk score was 16.1% ± 5.8%. RESULTS: All patients had successful transapical transcatheter mitral valve-in-valve implantation with no 30-day mortality. One patient died 45 days after surgical intervention from respiratory failure, and 1 patient died on day 135. All other patients were alive and in New York Heart Association class I/II at a median follow-up of 357 days. The median postprocedural transvalvular gradient was 7 mm Hg, and minimal transvalvular or paravalvular regurgitation was seen. CONCLUSIONS: Transcatheter transapical valve-in-valve implantations into a failed mitral bioprosthesis is technically feasible with acceptable results. It might be a viable approach for selected high-risk patients.

Influence of patient gender on mortality after aortic valve replacement for aortic stenosis.

OBJECTIVE: To assess the influence of gender on mortality after aortic valve replacement for aortic stenosis. METHODS: A retrospective analysis was performed on data prospectively collected from all patients undergoing aortic valve replacement for aortic stenosis. Multivariate regression analysis was performed to evaluate the effect of 22 preoperative and operative variables on early, late, and overall mortality. RESULTS: Aortic valve replacement was performed in 3343 patients with aortic stenosis between 1982 and 2003. The female patients were older, with a smaller body mass index. The women were less likely to have diabetes, chronic obstructive pulmonary disease, previous myocardial infarction, or left ventricular ejection fraction <35% but were more likely to have hypertension or a New York Heart Association III-IV classification. The female patients received a smaller prosthetic valve, with a smaller effective orifice area index (EOAI). The mean follow-up period was 6.18 ± 4.96 years, with a total of 2066.142 years of follow-up. The independent predictors of early mortality for the male patients included age, concomitant surgical revascularization, congestive heart failure, and valve size of ≤21 mm. The independent predictors of late mortality for the male patients included age, concomitant surgical revascularization, diabetes, renal failure, chronic obstructive pulmonary disease, congestive heart failure, and a bioprosthetic valve. The independent predictors of overall mortality for the male patients included age, concomitant surgical revascularization, diabetes, renal failure, heart failure, and valve size of ≤21 mm. For the female patients, the risk factors for early mortality included body mass index <25 kg/m(2); for late mortality included age, concomitant surgical revascularization, New York Heart Association class III-IV, and diabetes; and for overall mortality included age, concomitant surgical revascularization, New York Heart Association class III-IV, and renal failure. Furthermore, male gender was an independent predictor of late (but not early or overall) mortality. CONCLUSIONS: The independent predictors of mortality after aortic valve replacement for aortic stenosis differed between the male and female patients. Male gender increased the risk of late mortality, and a valve size of ≤21 mm increased the risk of early and overall mortality among the male patients only. These differences need to be taken into consideration preoperatively and require consideration during operative management.

Transatrial transcatheter tricuspid valve-in-valve implantation of balloon expandable bioprosthesis.

Transcatheter valve-in-valve implantation into failing mitral and aortic bioprosthetic valves have been reported. This strategy avoids performing high-risk repeat cardiac surgery in elderly patients with multiple comorbidities. Tricuspid valve-in-valve implantation has not been described. We report a case of failing bioprosthetic tricuspid valve in a 48-year-old woman with carcinoid syndrome. We attempted a transatrial transcatheter approach and we successfully deployed a 26-mm Edwards Sapien balloon expandable bioprosthesis (Edwards Lifesciences, Irvine, CA) into a severely stenotic tricuspid bioprosthesis. This case demonstrates the technical feasibility and safety of this approach. Therefore, tricuspid valve-in-valve implantation may be a viable treatment alternative in carefully selected patients.

Transcatheter valve-in-valve implantation for failed bioprosthetic heart valves.

BACKGROUND: The majority of prosthetic heart valves currently implanted are tissue valves that can be expected to degenerate with time and eventually fail. Repeat cardiac surgery to replace these valves is associated with significant morbidity and mortality. Transcatheter heart valve implantation within a failed bioprosthesis, a "valve-in-valve" procedure, may offer a less invasive alternative. METHODS AND RESULTS: Valve-in-valve implantations were performed in 24 high-risk patients. Failed valves were aortic (n=10), mitral (n=7), pulmonary (n=6), or tricuspid (n=1) bioprostheses. Implantation was successful with immediate restoration of satisfactory valve function in all but 1 patient. No patient had more than mild regurgitation after implantation. No patients died during the procedure. Thirty-day mortality was 4.2%. Mortality was related primarily to learning-curve issues early in this high-risk experience. At baseline, 88% of patients were in New York Heart Association functional class III or IV; at the last follow-up, 88% of patients were in class I or II. At a median follow-up of 135 days (interquartile range, 46 to 254 days) and a maximum follow-up of 1045 days, 91.7% of patients remained alive with satisfactory valve function. CONCLUSIONS: Transcatheter valve-in-valve implantation is a reproducible option for the management of bioprosthetic valve failure. Aortic, pulmonary, mitral, and tricuspid tissue valves were amenable to this approach. This finding may have important implications with regard to valve replacement in high-risk patients.

Transapical transcatheter aortic valve implantation: follow-up to 3 years.

BACKGROUND: We performed the first human case of successful transapical transcatheter aortic valve implantation on a beating heart in October 2005, and therefore we have the longest follow-up on transapical aortic valve implantation in humans. We now report clinical and echocardiographic outcomes of transapical aortic valve implantation in 71 patients. METHODS: Between October 2005 and February 2009, 71 patients (44 female) underwent transcatheter transapical aortic valve implantation with either 23- or 26-mm Edwards Lifesciences transcatheter bioprostheses. All patients with symptomatic aortic stenosis were declined for conventional aortic valve replacement owing to unacceptable operative risks and were not candidates for transfemoral aortic valve implantation because of poor arterial access. Clinical and echocardiographic follow-ups were performed before discharge, at 1 and 6 months, and then yearly. The mean follow-up was 12.9 +/- 11.5 months with a total of 917.3 months of follow-up. RESULTS: Mean age was 80.0 +/- 8.1 years and predicted operative mortality was 34.5% +/- 20.4% by logistic EuroSCORE and 12.1% +/- 7.7% by The Society of Thoracic Surgeons Risk Calculator. Valves were successfully implanted in all patients. Twelve patients died within 30 days (30-day mortality: 16.9% in all patients, 33% in the first 15 patients, and 12.5% in the remainder), and 10 patients died subsequently. Overall survival at 24 and 36 months was 66.3% +/- 6.4% and 58.0% +/- 9.5%, respectively. Among 59 patients who survived at least 30 days, 24- and 36-month survivals were 79.8% +/- 6.4% and 69.8% +/- 10.9%, respectively. Late valve-related complications were rare. New York Heart Association functional class improved significantly from preoperative 3.3 +/- 0.8 to 1.8 +/- 0.8 at 24 months. The aortic valve area and mean gradient remained stable at 24 months (1.6 +/- 0.3 cm(2) and 10.3 +/- 5.9 mm Hg, respectively). CONCLUSION: Our outcome suggests that transapical transcatheter aortic valve implantation provides sustained clinical and hemodynamic benefits for up to 36 months in selected high-risk patients with symptomatic severe aortic stenosis.

Technical considerations to avoid pitfalls during transapical aortic valve implantation.

OBJECTIVE: Transapical aortic valve implantation is a recent therapeutic advance for aortic valvular disease. We sought to identify complications--and the relevant technical and management considerations--from our learning curve with this procedure. METHODS: We retrospectively reviewed perioperative complications during the first 60 transapical aortic valve implantations at a single institution, performed under compassionate release for patients who were candidates neither for conventional aortic valve replacement nor for transfemoral aortic valve implantation. Access was through a small left anterolateral thoracotomy. Particular attention was paid to securing the apical access site. Rapid ventricular pacing to reduce cardiac forward flow was used during balloon valvuloplasty and valve deployment. Careful positioning was guided by echocardiography and fluoroscopy. RESULTS: This was a select, high-risk (mean Society of Thoracic Surgeons score, 12.3% +/- 7.8% mortality) cohort. Mean age was 81.1 +/- 7.8 years. Technical success was achieved in 59 (98.3%) cases. One valve was malpositioned too far toward the ventricle, necessitating that a second device be implanted within it. In-hospital, 30-day mortality was 18.3% (11 deaths) overall, decreasing from 33.3% in the first 15 patients to 13.3% in the subsequent 45 patients. The only intraoperative death probably resulted from left main ostial obstruction by extensively calcified aortic cusps. Significant left ventricular apical bleeding occurred in 3 (5.0%) patients. Other complications included stroke in 2 (3.3%) patients and permanent atrioventricular block in 3 (5.0%). There were 4 (6.6%) cases of late pseudoaneurysm of the left ventricular apical access site. CONCLUSIONS: Important lessons have been learned from our early experience with transapical aortic valve implantation, and these may guide others as this technology is adopted more broadly.

Effect of prosthesis-patient mismatch on long-term survival with aortic valve replacement: assessment to 15 years.

BACKGROUND: The effect of prosthesis-patient mismatch on long-term survival after aortic valve replacement has received considerable attention but there remains controversy. This study was performed to determine the predictors of mortality after aortic valve replacement and influence of prosthesis-patient mismatch on survival. METHODS: Contemporary mechanical prostheses and bioprostheses were implanted in 3,343 patients with aortic valve replacement between 1982 and 2003. The mean age was 68.06 +/- 11.20 years (median 70.06; range, 19 to 94), and the mean follow-up was 6.18 +/- 4.96 years, for a total of 20,666 years of follow-up. Prosthesis-patient mismatch was classified by effective orifice area index categories: normal (> 0.85 cm(2)/m(2)), 1,547 (46.3%); mild-to-moderate (> 0.65 cm(2)/m(2) to < or = 0.85 cm(2)/m(2)), 1,584 (47.4%); and severe (< 0.65 cm(2)/m(2)), 212 (6.3%). RESULTS: The predictors of overall mortality were age, age categorization, New York Heart Association functional class III/IV, concomitant coronary artery bypass graft surgery, prosthesis type, preoperative congestive heart failure, diabetes mellitus, renal failure, and chronic obstructive pulmonary disease. All categories of effective orifice area indexes were not predictive of overall mortality, late mortality, or early mortality. The 15-year overall survival was differentiated by effective orifice area index categories: 38.1% +/- 2.1%, 37.0% +/- 2.2%, and 22.1% +/- 6.5%, respectively, for the three categories. Survival adjusted for the covariates (effective orifice area index, age, basal mass index, and ejection fraction) determined no effect except severe effective orifice area index when adjusted for ejection fraction more than 50% (p = 0.049). CONCLUSIONS: Prosthesis-patient mismatch is not a predictor of overall standard unadjusted mortality to 15 years after aortic valve replacement, regardless of the category of effective orifice area index.

Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience.

OBJECTIVES: The aim of this study was: 1) to evaluate the acute and late outcomes of a transcatheter aortic valve implantation (TAVI) program including both the transfemoral (TF) and transapical (TA) approaches; and 2) to determine the results of TAVI in patients deemed inoperable because of either porcelain aorta or frailty. BACKGROUND: Very few data exist on the results of a comprehensive TAVI program including both TA and TF approaches for the treatment of severe aortic stenosis in patients at very high or prohibitive surgical risk. METHODS: Consecutive patients who underwent TAVI with the Edwards valve (Edwards Lifesciences, Inc., Irvine, California) between January 2005 and June 2009 in 6 Canadian centers were included. RESULTS: A total of 345 procedures (TF: 168, TA: 177) were performed in 339 patients. The predicted surgical mortality (Society of Thoracic Surgeons risk score) was 9.8 +/- 6.4%. The procedural success rate was 93.3%, and 30-day mortality was 10.4% (TF: 9.5%, TA: 11.3%). After a median follow-up of 8 months (25th to 75th interquartile range: 3 to 14 months) the mortality rate was 22.1%. The predictors of cumulative late mortality were peri-procedural sepsis (hazard ratio [HR]: 3.49, 95% confidence interval [CI]: 1.48 to 8.28) or need for hemodynamic support (HR: 2.58, 95% CI: 1.11 to 6), pulmonary hypertension (PH) (HR: 1.88, 95% CI: 1.17 to 3), chronic kidney disease (CKD) (HR: 2.30, 95% CI: 1.38 to 3.84), and chronic obstructive pulmonary disease (COPD) (HR: 1.75, 95% CI: 1.09 to 2.83). Patients with either porcelain aorta (18%) or frailty (25%) exhibited acute outcomes similar to the rest of the study population, and porcelain aorta patients tended to have a better survival rate at 1-year follow-up. CONCLUSIONS: A TAVI program including both TF and TA approaches was associated with comparable mortality as predicted by surgical risk calculators for the treatment of patients at very high or prohibitive surgical risk, including porcelain aorta and frail patients. Baseline (PH, COPD, CKD) and peri-procedural (hemodynamic support, sepsis) factors but not the approach determined worse outcomes.

Transcatheter valve-in-valve aortic valve implantation: 16-month follow-up.

Off-pump transcatheter, transapical valve-in-valve aortic valve implantation into a failed surgically implanted aortic valve was successfully performed in an 85-year-old man. He was discharged on postoperative day 5, and remained well at his 16-month follow-up. Echocardiography at 12 months showed normal prosthetic valve function without displacement, recoil, or regurgitation. Transcatheter transapical valve-in-valve aortic valve implantation is feasible and could be a viable approach for selected patients.