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Objectives: The number of cardiac implantable electronic devices is growing worldwide because they play a relevant role in improving the survival rate in patients with specific heart diseases. Cardiac implantable electronic devices complications including infection, dysfunction or venous stenosis increase the need for the least traumatic way to explant leads. Our goal was to report the successes and procedural complication rates of transvenous lead extraction (TLE) in a consecutive series of patients., Methods: From 2010 to 2016, 108 patients underwent TLE of 227 leads due to endocarditis (n = 21; 19%), pocket infection (n = 58; 54%) or lead dysfunction (n = 29; 27%). In 98% (n = 106) of the patients, laser-assisted lead extraction was performed. In 2% (n = 2) of the patients, the application of a solitary locking stylet was sufficient. The patient mean age was 68 ± 14 years; 25% of the patients had previous cardiac surgery. TLE was performed a mean of 9 ± 6 years after the implantation of the existing device., Results: Complete procedural success (removal of all lead material from the vascular space) was achieved in 98.7% (n = 224), and clinical success (achievement of all clinical goals associated with the indication for lead removal and absence of major complications) was achieved in 98% (n = 106). In 2 patients the procedure failed due to a vascular tear requiring a thoracotomy. In 1 patient, complete lead extraction was not possible due to heavy calcification (coronary-sinus lead). The 30-day mortality rate was 3.7% (n = 4); the patients died of multiorgan failure (n = 1), cardiac failure (n = 1) and septicaemia (n = 2). The procedure-related major complication rate was 2% (n = 2)., Conclusions: Laser-assisted TLE seems to be a safe and effective procedure with an acceptable complication rate., (© The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: The choice of prosthesis for aortic valve replacement in young and middle-aged patients remains challenging owing to the accelerated degeneration of bioprostheses in these age groups and the risks of thromboembolism and bleeding with mechanical valves. Theoretically, the living pulmonary autograft (Ross operation) would be advantageous. Long-term results of the various Ross techniques are needed for defining the value of this surgical concept., Methods: Of a total of 576 subcoronary Ross patients operated on between June 1994 and June 2011, we report on 203 consecutive subcoronary patients (mean age, 47.2±13.6 years, 155 male, 2,491 patient-years) with a follow-up of at least 10 years (mean, 12.3±2.9 years)., Results: Early and late mortality were 0.98% (n=2) and 11.4% (n=23). Valve-related mortality was 2.5% (n=5). Survival did not differ from that of the general German population. Freedom from autograft or allograft reoperation was 92.2% at 10 years and 87.1% at 15 years. Five major bleeding (0.20%/patient-year) and 11 thromboembolic events (0.44%/patient-year) occurred in 5 and 10 patients, respectively. Neither a systematic increase in aortic regurgitation nor an increase in root dimensions with time could be observed. In the vast majority of patients, valvular hemodynamics at latest echocardiographic follow-up were excellent., Conclusions: Long-term results of the original subcoronary Ross operation reveal normal survival, excellent hemodynamics, low risk of thromboembolism or bleeding, and small risk for reoperation. These results favor the pulmonary autograft concept in young and middle-aged patients in experienced centers and may serve to better define its role in surgical treatment of aortic valve disease in these patients., (Copyright © 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objective: Compared with reoperative aortic valve replacement for nonendocarditic causes, the contemporary risk and long-term outcomes of reoperation for aortic prosthetic valve endocarditis are ill-defined., Methods: Between December 1994 and April 2008, 313 patients underwent reoperative aortic valve replacement, of whom 152 (48.6%) had prosthetic valve endocarditis. Mean follow-up was 6.5 ± 0.4 years and 97.4% complete., Results: Patients with prosthetic valve endocarditis were older with a higher risk profile. The overall hospital mortality was 15.3% (n = 48) (prosthetic valve endocarditis vs nonendocarditis: 24.3%, n = 37, vs 6.8%, n = 11; P < .001). Independent predictors of perioperative mortality for prosthetic valve endocarditis were sepsis (odds ratio [OR], 6.5; 95% confidence interval [CI], 2.0-21.0; P < .01), ejection fraction less than 30% (OR, 5.8; 95% CI, 1.3-25.0; P = .02), concomitant coronary artery bypass grafting (OR, 3.3; 95% CI, 1.1-9.8; P = .03), and aortic root abscess (OR, 2.7; 95% CI, 1.2-6.4; P = .02), and for the nonendocarditis group were concomitant coronary artery bypass grafting (OR, 8.1; 95% CI, 2.0-33.0; P < .01), and mitral valve surgery (OR, 4.8; 95% CI, 1.3-17.9; P = .02). The 1-, 3-, 5-, and 10-year survivals for patients with and without prosthetic valve endocarditis were 52% ± 4% versus 82% ± 3%, 43% ± 5% versus 73% ± 4%, 37% ± 5% versus 63% ± 5%, and 31% ± 7% versus 56% ± 8%, respectively (log rank < 0.001). Predictors of long-term mortality in prosthetic valve endocarditis were sepsis (OR, 3.1; 95% CI, 1.5-4.5; P < .01) and unstable preoperative status (OR, 1.8; 95% CI, 1.2-3.5; P = .04), whereas in nonendocarditis patients the only predictor was New York Heart Association class IV (OR, 2.5; 95% CI, 2.8-7.4; P < .01). Five-year actuarial freedom from endocarditis was 80% ± 0.3% versus 95% ± 0.6% (prosthetic valve endocarditis cersus nonendocarditis; P = .002)., Conclusions: Despite contemporary therapy, reoperation for aortic prosthetic valve endocarditis is still associated with relatively high perioperative mortality and limited long-term survival., (Copyright © 2011. Published by Mosby, Inc.)

Background and Aim of the Study: The study aim was to assess long-term morbidity and mortality with special regard to prosthesis durability after aortic root replacement with the Hancock bioprosthetic porcine conduit., Methods: Between 1975 and 2004, a total of 81 patients (55 males, 26 females; mean age 58 +/- 18 years) underwent aortic root replacement with the Hancock conduit for aortic dissection (n = 22; 27%), ascending aortic aneurysm (n = 57; 70%), or porcelain aorta (n = 2; 3%). Twenty-five patients (31%) underwent an emergency operation, 12 (15%) presented with Marfan syndrome, and eight (10%) had undergone previous cardiac surgery. Concomitant procedures were performed in 26 cases (32%). The follow up was 98% complete; the mean follow up was 4.8 +/- 4.0 years (range: 1 day to 16.7 years), and the cumulative follow up was 403 patient-years. Actuarial event-free rates were calculated, and valve-related complications classified according to guidelines for reporting morbidity and mortality after cardiac valvular operations., Results: There were seven (9%) operative deaths and four (5%) in-hospital deaths. Actuarial survival rates at five and 10 years (excluding operative deaths) were 77.0 +/- 5.3% and 54.0 +/- 7.5%, respectively. Actuarial freedom from aortic valve reoperation at five and 10 years was 98 +/- 1.6% and 64 +/- 10.2%, from structural valve deterioration 88.1 +/- 4.7% and 49.9 +/- 9.6%, from thromboembolic events 87.4 +/- 4.6% and 75.1 +/- 9.5%, and from major bleeding events 90.2 +/- 3.9% and 75.4 +/- 8.1%, respectively. Among redo procedures, the stentless Hancock valve could be excised without separating the synthetic graft from the left ventricular outflow tract, and a stented valve prosthesis thus implanted. Hence, it was possible to avoid a second Bentall operation., Conclusion: The long-term survival rates after aortic root replacement with the bioprosthetic Hancock conduit were reasonable for this demanding patient cohort. However, the durability of the prosthesis was inferior to that reported for the stented Hancock valve substitute. The key benefit of this bioprosthetic valved conduit was the simplified redo procedure.

Background: The purpose of the study is to report major cardiac and cerebrovascular events after the Ross procedure in the large adult and pediatric population of the German-Dutch Ross registry. These data could provide an additional basis for discussions among physicians and a source of information for patients., Methods and Results: One thousand six hundred twenty patients (1420 adults; 1211 male; mean age, 39.2±16.2 years) underwent a Ross procedure between 1988 and 2008. Follow-up was performed on an annual basis (median, 6.2 years; 10 747 patient-years). Early and late mortality were 1.2% (n=19) and 3.6% (n=58; 0.54%/patient-year), respectively. Ninety-three patients underwent 99 reinterventions on the autograft (0.92%/patient-year); 78 reinterventions in 63 patients on the pulmonary conduit were performed (0.73%/patient-year). Freedom from autograft or pulmonary conduit reoperation was 98.2%, 95.1%, and 89% at 1, 5, and 10 years, respectively. Preoperative aortic regurgitation and the root replacement technique without surgical autograft reinforcement were associated with a greater hazard for autograft reoperation. Major internal or external bleeding occurred in 17 (0.15%/patient-year), and a total of 38 patients had composite end point of thrombosis, embolism, or bleeding (0.35%/patient-year). Late endocarditis with medical (n=16) or surgical treatment (n=29) was observed in 38 patients (0.38%/patient-year). Freedom from any valve-related event was 94.9% at 1 year, 90.7% at 5 years, and 82.5% at 10 years., Conclusions: Although longer follow-up of patients who undergo Ross operation is needed, the present series confirms that the autograft procedure is a valid option to treat aortic valve disease in selected patients. The nonreinforced full root technique and preoperative aortic regurgitation are predictors for autograft failure and warrant further consideration. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00708409.

Background: The purpose of this study was to collect the experience gained from risk assessment of incidents associated with mechanical heart valves as reported to the German Medical Devices Vigilance System., Methods: All events in connection with the use of prosthetic heart valves which had been reported to the Federal Institute for Drugs and Medical Products were identified in the Institute's anonymized database. Subsequently all information that had been obtained and the reports of investigations by the various responsible manufacturer of medical products were retrospectively analysed., Results: Of 53 incident reports the aortic valve position was involved 32 times, the mitral valve position 21 times. 17 cases of leaflet breakage, 12 of leaflet dysfunction, 6 of valve thrombosis, 4 of paravalvular leakage, 4 of damage to the suture ring, 3 of endocarditis and 7 of various other singular defects were reported. The outcome was mostly very serious (re-surgery, prolongation of surgery, death). Corrective actions taken by the manufacturers consisted of recalls, advisory notices and stoppage of production., Conclusions: The Medical Devices Vigilance System is able to detect product failures of mechanical heart valves and to initiate corrective action. As the reporting rate over more than 10 years is relatively low, it can be assumed that in general mechanical heart valves are safe medical devices. The quality of incident reporting by manufactures and users of medical devices should be improved to reduce the number of undetected and unsolved incidents.