Adverse Valve-related Events Research Articles

An Australian-based Outreach Program of Valve Replacement Surgery for Rheumatic Heart Disease in Fiji: Early and Late Mortality, and Major Adverse Valve-related Events, Over a 10 Year Period, 2001–2011

An Australian-based Outreach Program of Valve Replacement Surgery for Rheumatic Heart Disease in Fiji: Early and Late Mortality, and Major Adverse Valve-related Events, Over a 10 Year Period, 2001–2011

Transaxillary Approach Short- and Mid-Term Results in a Single-Center Experience

Transcatheter aortic valve implantation (TAVI) is increasingly accepted as an alternative procedure in patients with severe, symptomatic aortic stenosis and high risk for surgical aortic valve replacement. Transfemoral (TF) approach is the first option when feasible, but in case of peripheral vascular disease this approach is precluded. In our institution, for this kind of patients we considered transaxillary (TAx) approach as second choice and transapical (TAp) or transaortic (TAa) as last routes. This study describes short- and mid-term morbidity and mortality for TAx approach. From November 2007 to March 2011, 284 patients underwent TAVI at our site; 229 treated by TF approach, 22 TAp, 2 TAa, and 31 TAx. Four patients were treated with an Edwards Sapien valve (Edwards Lifesciences, Inc., Irvine, CA USA) with TAx approach and 27 with CoreValve Revalving System (Medtronic Inc., Minneapolis, MN USA). TAx TAVI was performed in cath-laboratory with local anesthesia and mild sedation by a multispeciality valve team. We analyzed major adverse cardiac and cerebrovascular events, major adverse valve-related events, vascular complications, and 30 days and 6 months mortality. The procedural success rate (successful implantation of the device without intraprocedural mortality or need to conversion to open heart surgery) was 96.8% (30/31). Major adverse valve-related events were 12.9% (4/31). 30-day mortality was 6.4% (2/31) and actuarial survival at 6 months was 82.95% ± 7.96%. In one patient, procedure was converted to a TF CoreValve in emergency for hemodynamic instability after valvuloplasty due to severe difficulty to introduce the Edwards valve in the subclavian artery. TAx approach is a feasible and technically simple procedure with encouraging results considering morbidity and mortality at short- and mid-term follow-up. TAx is a valid solution in patients with contraindications to TF approach and it is an alternative approach potentially less invasive than TAp or TAa.

Transapical Aortic Valve Implantation in High-Risk Patients With Severe Aortic Valve Stenosis

Transapical aortic valve implantation (TA-TAVI) represents an alternative in patients with symptomatic severe aortic valve stenosis (SSAVS) who cannot be operated on or have a high surgical risk. The aim of this prospective multicenter observational study was to assess early and 2-year clinical and hemodynamic outcomes after TA-TAVI. From May 2008 to September 2010, 179 patients with inoperable conditions or high-risk patients underwent TA-TAVI at 4 institutions. Indications for TA-TAVI were SSAVS and logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) greater than 20% or porcelain aorta in patients with severe aortoiliac disease. Patients underwent clinical and echocardiographic follow-up visits at hospital discharge, 3 and 6 months after TA-TAVI, and every 6 months thereafter. The impact of the learning curve for the centers and of intraoperative complications on patient outcomes was also evaluated. Mean age was 81 ± 6 years. Mean logistic EuroSCORE was 22% ± 12%. Transapical delivery was successful in all patients. Seventeen severe intraoperative complications occurred in 13 (7.3%) patients. Thirty-day mortality was 3.9% (7 patients). Mean follow-up was 9.2 ± 6.5 months. Late mortality occurred in 9 patients. Two-year survival was 88% ± 3%. An intraoperative severe complication was identified as the only significant independent predictor of 1-year mortality. A significant benefit was found when comparing 2-year survival of the second versus the first 50% patients at each center (93% ± 2% versus 84% ± 3 %; p = 0.046). A significant reduction of both mean and peak gradients from the preoperative to the postoperative period, which remained stable during follow-up, was found. TA-TAVI provides excellent early and 2-year results in terms of survival, valve-related adverse events, and hemodynamic performance. Survival after TA-TAVI is affected by the center learning curve and by the occurrence of an intraoperative complication.

Hemodynamic and Clinical Impact of Prosthesis–Patient Mismatch After Transcatheter Aortic Valve Implantation

This study examined the mid-term hemodynamic and clinical impact of prosthesis-patient mismatch (PPM) in patients undergoing transcatheter aortic valve implantation (TAVI) with balloon-expandable valves. PPM can be observed after aortic valve surgery. However, little is known about the incidence of PPM in patients undergoing TAVI. Echocardiography and clinical assessment were performed in 165 patients at baseline, before hospital discharge, and at 6 months after TAVI. PPM was defined as an indexed effective orifice area ≤0.85 cm(2)/m(2). Thirty patients (18.2%) showed PPM before hospital discharge. At baseline, patients with PPM had a larger body surface area (1.84 ± 0.18 m(2) vs. 1.73 ± 0.18 m(2), p = 0.003) and a greater severity of aortic stenosis (indexed valve area 0.35 ± 0.09 cm(2)/m(2) vs. 0.40 ± 0.10 cm(2)/m(2), p = 0.005) than patients without PPM. Patients with PPM demonstrated a slower and smaller reduction in mean transaortic gradient, limited left ventricular (LV) mass regression, and left atrial volume reduction over 6 months compared with patients without PPM. LV filling pressure, measured by E/e', tended to remain elevated in patients with PPM. Importantly, a higher proportion of patients with PPM did not improve in New York Heart Association functional class compared with patients without PPM (36.7% vs. 1.5%, p < 0.001), although major adverse valve-related and cardiovascular events did not differ between the 2 groups. PPM may be observed after TAVI and when present may be accompanied by less favorable changes in transvalvular hemodynamics, limited LV mass regression, persistent elevated LV filling pressure, and less improvement in clinical functional status.

Mid-Term Results of Mitral Valve Repair Using a Partial Flexible Band and a Completely Rigid Ring in Patients with Degenerative Mitral Regurgitation

Background: We evaluated mid-term results of mitral annuloplasty using a flexible band and a completely rigid ring for mitral valve repair in patients with degenerative mitral regurgitation (MR). Material and Method: From January 2004 to September 2008, 71 patients (M:F=36：35, 55±13 years) underwent mitral valve repair with mitral annuloplasty for degenerative MR. Ring annuloplasty was done using a Cosgrove-Edwards flexible band (Group Ⅰ, n=43) or a Carpentier-Edwards classic ring (Group Ⅱ, n=28). There were no differences in preoperative characteristics of the participants. Average duration of follow-up was 36 months (range: 2~69 mos). Result: There was no in-hospital mortality. Postoperative morbidity, which included atrial fibrillation (n=7) and low cardiac output syndrome (n=5) in groups Ⅰ and Ⅱ were similar. There was one late death in group Ⅱ. The proportion exhibiting freedom from recurrent mitral regurgitation (≥moderate) at 4 years in Groups Ⅰ and Ⅱ were, respectively, 94.5 and 91.8%, (p=0.695). Left ventricular ejection fraction decreased in the early postoperative period (7±2 days) and recovered by last follow-up (25±16 mos; p=0.002). The pattern was similar in groups Ⅰ and Ⅱ (p=0.905). Re-operation was performed in 3 patients (1 in Group Ⅰ and 2 in Group Ⅱ, p=0.316). Four-year event-free survival (free of adverse valve-related events) was 95.2% for Group Ⅰ and 92.6% for Group Ⅱ; this difference was not significant, p=0.646). Conclusion: The type of technique used in mitral annuloplasty to repair the mitral valve repair after degenerative MR did not affect mid-term clinical and functional results.

Safety and Efficacy of the Subclavian Approach for Transcatheter Aortic Valve Implantation With the CoreValve Revalving System

Transcatheter aortic valve implantation (TAVI) is a new option for patients with severe aortic stenosis at high surgical risk. The standard retrograde approach through the femoral artery is contraindicated in case of unfavorable iliofemoral anatomy or extensive disease. In these patients, a trans-subclavian approach may be feasible. Between June 2007 and July 2009, TAVI with the CoreValve bioprosthesis (Medtronic, Minneapolis, Minn) was performed in 514 consecutive patients at 13 Italian hospitals, using the subclavian approach in 54 cases. The median logistic EuroSCORE was significantly higher in the subclavian (19.4; interquartile range, 12.5 to 29.8) versus femoral group (25.3; interquartile range, 15.1 to 36.6) (P=0.03), as well as the rate of comorbidities. Procedural success was obtained in 100% versus 98.4% of the subclavian versus femoral groups, respectively (P=0.62), with intraprocedural mortality of 0% versus 0.9% (P=1.00). The most common in-hospital complications were a new left bundle-branch block (22.4%) and the need for pacemaker (16.3%). No specific complications for the subclavian access (vessel rupture, vertebral or internal mammary ischemia) were reported. The learning curve for the subclavian approach led to a wider use of local anesthesia. Thirty-day mortality was 0% versus 6.1% in the subclavian versus femoral groups, respectively (P=0.13). Six-month mortality rate was 9.4% versus 15.8% (P=0.44), whereas valve-related adverse events were 13.6% versus 13.9% (P=0.79). TAVI through the subclavian approach appeared feasible and safe, with excellent procedural success and low in-hospital complication rates. This new technique allows patients with contraindications to the femoral approach to be treated with TAVI.

A North American, Prospective, Multicenter Assessment of the Mitroflow Aortic Pericardial Prosthesis

The aim of the Mitroflow aortic pericardial valve study was to prospectively assess performance of the Mitroflow prosthesis among North American patients. The study was conducted between November 2003 and December 2007 on patients requiring aortic valve replacement. The study cohort consisted of 689 patients (391 male, 298 female), with a mean age of 74.3 +/- 8.4 years, and 46.6% of whom were New York Heart Association (NYHA) class I/II preoperatively. Patients were followed at 3 to 6 months and yearly until study closure. Mean follow-up was 25.7 +/- 12 months, and total follow-up was 1,474.4 patient-years, with a maximum of 48.7 months. Postoperatively, more than 97% of evaluated patients were NYHA class I/II. At 3 years, 131 patients had died, for an actuarial survival of 79.1%; and the 3-year actuarial freedom from valve-related death, valve explant, all valve reoperation, and structural valve dysfunction was 97.0%, 98.1%, 97.9%, and 99.2%, respectively. Other valve-related complications included prosthetic valve endocarditis (1.4% per patient-year), thromboembolic episodes (1.3% per patient-year), major embolism (0.5% per patient-year), perivalvular leak (0.6% per patient-year), and major anticoagulation-related bleeding (0.6% per patient-year). Echocardiograms at 1 year showed mean pressure gradients averaged from 7.3 +/- 1.8 mm Hg to 13.4 +/- 5.1 mm Hg, and peak gradients averaged from 14.3 +/- 4.7 mm Hg to 26.0 +/- 9.2 mm Hg for valve sizes 27 to 19. Aortic regurgitation in patients was absent/trace (90.2%) or mild (8.7%); none was severe. The early results of this study show a low incidence of valve-related adverse events and excellent hemodynamic performance. Continued follow-up is needed to determine if long-term durability in North American patients is comparable to that in previous reports on the durability of the Mitroflow valve.

Long-term follow-up of elderly patients subjected to aortic valve replacement with mechanical prostheses

We propose to analyse the long-term follow-up in patients older than 65 years of age who received a mechanical valve in the aortic position, using death and prosthetic-related complications as endpoints. From April 1988 to December 1995, 144 consecutive patients 65-75 years of age (mean 67.7+/-2.5) were enrolled. Total duration of follow-up was 1663 patient-years (median 13.0 years) and was complete for 99% of the patients. Thirty-day mortality was 1.4% (n=2). At the end of the study, 77 patients (53.8%) were alive, with ages ranging from 77 to 91 years (mean 82.1+/-3.2 years). The overall 5-, 10- and 15-year actuarial survival was 87.4%+/-3.0, 67.7%+/-4.3 and 58.5%+/-4.5, respectively. Freedom from stroke was 93.3+/-3.1%, 84.6+/-3.3% and 71.7+/-4.5%, respectively, after identical periods. Freedom from major bleeding was 97.2+/-1.1%, 90.4+/-3.5% and 86.4+/-4.0%, respectively. Freedom from endocarditis was 95.7+/-2.3%, 95.0+/-2.1% and 94.4+/-2.5%, respectively, and freedom from reoperation was 98.0+/-1.2%, 97.6+/-1.3%, 96.9+/-2.4% and 96.4+/-2.6%, respectively. Freedom from major valve-related events was 87.7+/-2.6%, 73.9+/-3.4% and 61.5+/-4.6%, respectively. Nearly two-thirds of the patients were alive and free from major adverse valve-related events. Hence, we consider implantation of a mechanical prosthesis in elderly patients safe and appropriate, but the choice must be tailored for each specific patient.

Mosaic valve international clinical trial: early performance results

Background. A new third generation porcine bioprosthesis was developed in an attempt to improve on hemodynamic performance and durability of current prostheses.Methods. One thousand, two hundred, sixty patients underwent aortic valve replacement and 366 patients underwent mitral valve replacement between February 1994 and September 2000. The cumulative follow-up was 3,696.3 patient-years for aortic valve replacement and 880.1 patient-years for mitral valve replacement. Follow-up was complete for 95.5% of aortic valve replacement patients and 97.5% of mitral valve replacement patients.Results. For aortic valve replacement, freedom from valve-related adverse events at 1 year was 96.5% ± 0.5% for antithromboembolic-related hemorrhage and 100% for structural valve deterioration. Freedom from valve-related adverse events at 5 years was 93.8% ± 2.6% for antithromboembolic-related hemorrhage and 99.3% ± 0.9% for structural valve deterioration. For mitral valve replacement, freedom from valve-related adverse events at 1 year was 96.0% ± 1.1% for antithromboembolic-related hemorrhage and 100% for structural valve deterioration. Freedom from valve-related adverse events at 4 years was 92.1% ± 3.7% for antithromboembolic-related hemorrhage and 100% for structural valve deterioration.Conclusions. These results support the claim that the Mosaic bioprosthetic valve is efficacious and safe, but continued follow-up is mandatory to determine mid- and long-term performance.

Clinical outcomes after aortic valve replacement with the Toronto stentless porcine valve

Background. Hemodynamic benefits of the Toronto stentless porcine valve have been documented. Clinical well-being and freedom from major valve-related events have been less well defined.Methods. A total of 447 patients were prospectively followed for up to 8 years (1,745.2 valve years total, 3.9 valve years/patient). The patient demographics included 66% men, mean age 65 years, New York Heart Association functional class III–IV 55%, concomitant coronary artery bypass grafting 41%.Results. We found that 83.7% of patients were in New York Heart Association functional class I and 80.8% had 0 to 1+ aortic insufficiency. Mean gradient at 6 years (n = 75) was 4.4 mm Hg and mean effective orifice area (EOA) 2.4 cm2. Late adverse event rates per patient per year were: embolism 1.0%, endocarditis 0.4%, thrombosis 0%, structural deterioration 0.2%, explant 0.3%, and valve-related death 0.6%. Freedom from valve-related death at 6 years was 95.8%; from cardiac death 96.3%. Freedom from endocarditis was 98.4%, from embolism 93.9%, from structural deterioration 97.4%, and freedom from explant 98.1%. For patients older than 60 years, freedom from structural deterioration was 100%.Conclusions. These results confirm satisfactory clinical outcomes after aortic valve replacement with the Toronto stentless porcine valve, with a low incidence of valve-related adverse events as long as 96 months after valve replacement.