Mirko Doss

Transapical Minimally Invasive Aortic Valve Implantation: Multicenter Experience

Background— To evaluate initial multicenter results with minimally invasive transapical aortic valve implantation (TAP-AVI) for high risk patients with aortic stenosis. Methods and Results— TAP-AVI was performed via a small anterolateral minithoracotomy with or without femoro-femoral extracorporeal circulation (ECC) on the beating heart. A pericardial xenograft fixed within a stainless steel, balloon expandable stent (Edwards SAPIEN THV, Edwards Lifesciences) was used. Fifty-nine consecutive patients (81±6 years, 44 female) were operated on from 02/06 until 10/06 at 4 centers using fluoroscopic and echocardiographic visualization. Average EuroSCORE predicted risk for mortality was 27±14%. TAP valve positioning was performed successfully in 53 patients, 4 required early conversion to sternotomy. Implantation (23-mm valves in 19 and 26-mm valves in 40 patients) was performed on the beating heart during brief periods of rapid ventricular pacing. Thirty-one patients were operated on without cardiopulmonary bypass. Neither coronary artery obstruction nor migration of the prosthesis was observed, and all valves had good hemodynamic function. Echocardiography revealed minor paravalvular leakage in 26 patients (trace in 11, mild in 12, and severe in 3). Eight patients died in-hospital (13.6%) without any valve dysfunction. Actuarial survival was 75.7±5.9% at a follow-up interval of 110±77 days (range 1 to 255 days). Conclusions— TAP-AVI can be performed safely with good early results in high risk patients. Long-term valve performance as well as broader based applications of this promising approach will need to be studied.

Surgical versus endovascular treatment of acute thoracic aortic rupture: a single-center experience

BACKGROUND Surgical management of acute thoracic aortic ruptures is controversial, especially in patients with preexisting comorbidities; associated mortality and paraplegia rates remain high. It was our objective to evaluate whether treating these patients acutely with endovascular stent grafts would improve their outcome. METHODS From November 1999 to February 2002 a total of 54 patients, age 28 to 83 years, were admitted to our institution with an acute rupture of the thoracic aorta (24 ruptured aneurysms, 14 perforated type B dissections, 16 traumatic ruptures). Twenty-eight patients were managed surgically using cardiopulmonary bypass (group 1), and 26 patients were treated acutely with an endovascular stent graft (group 2). The resuscitation protocol and interval from onset of symptoms to treatment was comparable in both groups. Medical records were reviewed for prehospitalization and emergency department data, operative findings, and outcomes. RESULTS There were 5 of 28 deaths (17.8%) in the surgical group and 1 of 26 deaths (3.8%) in the endovascular group. In the surgical group 1 of 28 patients (3.6%) exhibited paraplegia; there were no cases of paraplegia in the endovascular group. There were 4 of 28 cases (14.3%) of renal failure in group 1 and 1 of 26 (3.8%) in group 2. In group 1, 8 patients (28.6%) required mechanical ventilation for more than 48 hours; there were 2 of 26 patients (7.7%) in group 2 with this ventilatory requirement. Three patients required a repeat thoracotomy for hemorrhage in the surgical group. There were two access failures in the endovascular group. CONCLUSIONS In the treatment of acute ruptures of the thoracic aorta, the immediate outcome of patients treated with endovascular stent grafts appears to be better than with management by conventional surgical repair.

Vacuum-assisted suction drainage versus conventional treatment in the management of poststernotomy osteomyelitis

OBJECTIVE The purpose of our study was to compare vacuum-assisted suction drainage (VASD) to conventional wound management, in the treatment of poststernotomy osteomyelitis (SOM). METHODS We included a total of 42 patients that developed poststernotomy osteomyelitis and required open wound management, between 1998 and 2000, in this study. Twenty of these patients were treated by VASD and the other 22 by conventional wound management. The patients were well comparable with regards to age, presenting postoperative day, infecting organism and risk factors for osteomyelitis. This was a retrospective study. RESULTS The patients treated by VASD had a significantly reduced treatment duration (mean 17.2+/-5.8 vs. 22.9+/-10.8 days, P=0.009) and total hospital stay (mean 27.2+/-6.5 vs. 33.0+/-11.0 days, P=0.03). Perioperative mortality was similar, with one early death in each group. CONCLUSION We conclude from our experience in the treatment of 42 patients with poststernotomy osteomyelitis that VASD shortened wound healing and hospital stay and thus proved to be an excellent alternative to conventional open management of these wounds.

The transapical approach for aortic valve implantation.

OBJECTIVE Percutaneous aortic valve implantation has been performed clinically in high-risk patients with severe aortic stenosis. Transfemoral retrograde valve delivery is limited by concomitant peripheral vascular disease and the size of the delivery system. We report on the alternative transapical approach that allows accurate antegrade placement of a catheter-deliverable aortic valve. METHODS Over a 2-year period, 26 consecutive patients (84.3 +/- 6.5 years) were treated at our center. Transapical aortic valve implantation was performed with 23-mm and 26-mm pericardial valves (Cribier-Edwards; Edwards Lifesciences, Irvine, Calif) mounted on a stainless steel stent. A limited anterolateral incision, in the fifth intercostal space, was used to access the apex of the heart. The valve was crimped, placed into a 24F sheath, and introduced into the left ventricle through purse-string sutures. Fluoroscopy and transesophageal echocardiography were used to guide the catheter across the native valve and to direct deployment of the stent at the level of the annulus. During deployment, the heart was unloaded with extracorporeal support or with rapid ventricular pacing. The average logistic EuroSCORE-predicted risk for mortality was 36.5% +/- 5.8%. RESULTS All valves were successfully deployed at the target. On echocardiography, all valves showed good hemodynamic function with only minor paravalvular leakages. The mean transaortic valve gradient was 6 +/- 2 mm Hg. Thirty-day mortality was 15% (n = 4). One patient died of perforation of the right ventricle and 1 of dissection of the aortic root. There were 2 cases of conversion to open surgery. In 2 patients, the left main stem was partially obstructed by the native valve and required stent angioplasty. CONCLUSIONS Initial results of the transapical approach are encouraging. Long-term studies and randomized protocols will be required to further evaluate this procedure.

One-year interim follow-up results of the TRAVERCE trial: the initial feasibility study for trans-apical aortic-valve implantation

OBJECTIVES To evaluate the interim results of the initial multicenter feasibility trial for trans-apical aortic-valve implantation (TA-AVI) in high-risk elderly patients with severe aortic stenosis. METHODS A total of 168 patients were prospectively included in three European centers between February 2006 and April 2008. The Cribier-Edwards or Edwards SAPIEN™ Trans-catheter Heart Valve (23 mm and 26 mm) was implanted using an oversizing concept. Interventions were performed in a hybrid operative room (OR) (one center), with a mobile C-arm in the OR (one) and in the catheterization laboratory (one). Inclusion criteria included age ≥70 years and an increased risk profile (additive European System for Cardiac Operative Risk Evaluation (EuroSCORE) ≥9). RESULTS Patient age was 82.1±5.6 years, 76% were female and the EuroSCORE was 11.3±1.8 (additive) and 27±12.7% (logistic). Cardiopulmonary bypass was used by intention in 14.2% during the initial phase, secondarily in 10.1% and 75% of the patients were treated off-pump. Valve implantation led to a good immediate result in 161 (95.8%) patients and problems were encountered in seven patients (malposition (two patients), migration (three patients) and severe incompetence (two patients)). Nine patients were converted to conventional surgery, early stroke occurred in two (1.2%) patients and 10 (6%) patients received a new pacemaker. At 30 days, 25 patients died, 48% of them due to cardiac-related causes. Overall survival at 30 days, 6 months and 1 year was 85%, 70% and 63%, respectively. CONCLUSIONS The initial multicenter feasibility trial for TA-AVI (TRAVERCE) shows acceptable results of this promising technique, especially in view of the high-risk profile of the patients.

Sutureless Aortic Valve Replacement With the 3f Enable Aortic Bioprosthesis

PURPOSE Important comorbid conditions in elderly patients referred for aortic valve replacement require alternative treatment options with possible reduction of the extracorporeal circuit time and reliable hemodynamic features. We report on clinical experiences with the sutureless, nitinol-stented 3f Enable (ATS Medical, Minneapolis, MN) aortic valve prosthesis in 32 patients. DESCRIPTION The procedure was performed using cardiopulmonary bypass with cardioplegic arrest. After resection of the stenotic aortic valve and debridement of the annulus, the valve was inserted and released. Mean age was 78 +/- 3; mean logistic Euroscore was 13.7. Concomitant procedures were mitral valve and tricuspid valve repair (n = 1), coronary artery bypass graft (n = 9), and subvalvular myectomy (n = 3). EVALUATION Implantation of the valve required 9 +/- 5 minutes. Cardiopulmonary bypass and aortic cross-clamp time were 87 +/- 16 and 55 +/- 11 minutes for stand-alone procedures. Combined procedures required 126 +/- 42 and 84 +/- 28 minutes, respectively. Two patients were abandoned intraoperatively and converted to standard procedures due to misalignment of the valve. In the other 30 patients, no paravalvular leakage was detected. The transvalvular gradient at discharge was 9 +/- 6 mm Hg (mean) and 18 +/- 9 mm Hg (peak). Six months after surgery, gradients were 10 +/- 4 mm Hg (mean) and 18 +/- 6 mm Hg (peak). CONCLUSIONS Sutureless valve implantation is feasible and safe with the 3f Enable (ATS Medical) bioprosthesis. Reduction of cardiopulmonary bypass and aortic cross-clamp time seems to be possible with increasing experience. Hemodynamic data are promising with low gradients at discharge and after 6 months.

Is transapical aortic valve implantation really less invasive than minimally invasive aortic valve replacement

BACKGROUND Transcatheter valve implants currently draw their justification for use from reduction of perioperative risk. However, patient age and comorbidities are independent predictors of adverse outcome after aortic valve replacement, regardless of surgical approach. Therefore, it is unclear whether transapical aortic valve implantation really improves outcomes in high-risk patients. METHODS We included a total of 51 high-risk patients with severe aortic valve stenosis. Patients were allocated to transapical aortic valve implantation (n = 21) or minimally invasive aortic valve replacement via a partial upper sternotomy (n = 30), in a nonrandomized fashion. Patient age, preoperative comorbidities, and perioperative risk, expressed as logistic EuroSCORE (38% +/- 14% vs 35% +/- 9%), were matched between the 2 groups. RESULTS Early morbidity and mortality were comparable between groups, but transapical aortic valve implantation was associated with shorter operative time (P = .004), ventilation time (P < .001), intensive care unit stay (P < .001), and hospital stay (P < .001). Thirty-day mortality was 14% (n = 3) in the transcatheter group versus 10% (n = 3) in the surgical group. After a mean follow-up of 12 +/- 4 months (100% complete), there were a total of 5 (24%) deaths in the transapical group versus 5 (17%) deaths in the open surgery group. There was 1 intraoperative death in the transapical group versus none in the surgery group. In the transapical group, there were 2 re-explorations for bleeding, 2 intraoperative conversions, 1 case of prosthesis migration, and 2 impairments of coronary arteries. The surgery group included 1 re-exploration, 1 stroke, 1 pacemaker implantation for complete atrioventricular block, and 3 cases of atrial fibrillation. CONCLUSIONS Current data suggest a faster postoperative recovery after transapical aortic valve implantation, with early and late morbidity and mortality comparable with those of minimally invasive aortic valve replacement via partial upper sternotomy.

The clamshell approach for the treatment of extensive thoracic aortic disease

OBJECTIVE Management of extensive thoracic aortic disease may present an immense technical challenge. The choice of surgical access and subsequent exposure determines whether a single-stage or a 2-stage approach can be adopted. METHODS Fifteen patients with extensive thoracic aortic disease underwent resection of the ascending aorta, the aortic arch, and varying segments of the descending aorta. Four patients had concomitant coronary artery bypass grafting and 3 patients had aortic valve reconstruction. All patients were treated with a single-stage approach via a bilateral anterior thoracosternotomy (clamshell incision). RESULTS There was 1 hospital death (6.6%). Two patients required reoperation for bleeding (13.3%). Two patients needed mechanical ventilation for more than 48 hours. Three patients suffered a stroke (20%). Two patients (13.3%) had transient neurologic dysfunction. None of the patients had renal failure. There were no wound infections in this group. CONCLUSION The single-stage approach, via a clamshell incision, is a safe and effective procedure for patients who require treatment of extensive thoracic aortic disease and concomitant cardiac lesions.

Thrombotic Restenosis After Minimally Invasive Implantation of Aortic Valve Stent

An 84-year-old woman underwent successful, minimally invasive, transapical aortic valve implantation (Edwards SAPIEN 23 mm) to address symptomatic high-grade aortic stenosis and logistic EuroScore of 22%. Echocardiographic control after 11 and 41 days demonstrated the valve in good position without relevant paravalvular leakage or aortic regurgitation. Mean gradients over aortic valve implant were 17 mm Hg and 19 mm Hg, respectively. At echocardiographic follow-up at 6 and 8 months, mean gradient increased to 40 mm Hg and 53 mm Hg, respectively. The patient also developed dyspnea on exertion again. Transesophageal echocardiography at 8 months demonstrated 1 well opening aortic valve leaflet at the septal side, whereas an echodense structure was visible at the opposite side (Figure 1 …

The STS score is the strongest predictor of long-term survival following transcatheter aortic valve implantation, whereas access route (transapical versus transfemoral) has no predictive value beyond the periprocedural phase

OBJECTIVES Transcatheter aortic valve implantation (TAVI) was developed as a promising new therapy for inoperable and surgical high-risk patients as an alternative to traditional aortic valve replacement. After a successful procedure, prognosis may mainly be determined by comorbidities. However, no appropriate risk score to predict long-term outcome following TAVI is currently available. The aim of this study was to identify predictors of adverse short- and long-term outcomes. METHODS This is a two-centre registry study including a total of 426 TAVI procedures (274 transfemoral [TF] and 152 transapical [TA]) performed at the University Hospital and CardioVascular Center of Frankfurt (Germany) between 2005 and 2011. RESULTS Observed 30-day mortality was 4.8% among TF and 12.6% among TA patients (hazard ratio [HR] TF vs TA was 0.38; 95% confidence interval [CI] 0.19-0.77). Patients with a higher Society of Thoracic Surgeons (STS) score experienced a 6% elevation in the 30-day mortality per point (HR 1.06; 95% CI 1.03-1.10), whereas the predictive value of the logistic EuroSCORE (HR 1.03; 95% CI 1.01-1.05) and EuroSCORE 2 (HR 1.04; 95% CI 1.01-1.07) was slightly lower. Most interestingly, older age (>80 years) and the access type were predictors of 30-day mortality. However, the only independent predictor of long-term mortality in a 30-day landmark analysis was the STS score (HR 1.05; 95% CI 1.02-1.09). CONCLUSIONS The STS score outperforms the logistic EuroSCORE in predicting adverse outcomes following TAVI. The transapical approach is associated with higher perioperative mortality, but does not exert any influence on long-term prognosis beyond the periprocedural phase.