Stefan Sorg

The Jarvik 2000 is associated with less infections than the HeartMate left ventricular assist device

OBJECTIVES Device-related infections remain a considerable problem of left-ventricular support. We compared the device-related-infections between the HeartMate left ventricular assist device (LVAD) and the Jarvik 2000 permanent LVAD, a device with a novel retroauricular power-supply. METHODS Between December 2000 and September 2002 we implanted the HeartMate-vented, electrical-system in 11 patients and the permanent Jarvik 2000 in six patients. Total support time was 1626 patient-days (HeartMate, 26-271 days) versus 1246 patient-days (Jarvik 2000, 8-411 days). As potential risk factors for infection we analyzed age, preoperative hospital-days, total protein, cardiac index, maximal oxygen uptake, use of inotropes, LVAD risk-score-index and Aaronson-Mancini-score, intubation time, and intensive care unit stay. We used the Center of Disease Control definitions for surgical site infections. RESULTS HeartMate-patients were younger than Jarvik 2000 patients (46+/-13 versus 58+/-6 years, P=0.056), there were no other differences in the risk factors. Four HeartMate-patients needed late (>or=48 h) surgical revisions for bleeding/hematomas versus no revisions in the Jarvik 2000 patients. In the HeartMate-patients, there were seven (64%) driveline-infections, five (45%) device-pocket infections, and three (27%) bloodstream-infections, or 0.43 device-related infections/100 patient-days. Infections occurred early (34+/-31 days). Three patients required urgent transplantation due to bloodstream infection. There were no adverse outcomes in the HeartMate-group due to infection. In the Jarvik 2000 patients, there was one driveline-infection (16%) after 270 days of support (0.08 device-related infections/100 patient-days), significantly less than in the HeartMate-group (P=0.044). Driveline infections resolved with antibiotics and local wound care in the Jarvik 2000 patient, but only in one of seven HeartMate-patients. CONCLUSIONS Implantation of the Jarvik 2000 is associated with less device-related infections than the HeartMate-LVAD. The power-supply of the permanent Jarvik 2000 is suitable for long-term mechanical support.

Transapical aortic valve implantation using a new self-expandable bioprosthesis (ACURATE TA ™ ): 6-month outcomes †

OBJECTIVES The ACURATE TA(™) Aortic Bioprosthesis and Delivery System (Symetis S.A., Ecublens, Switzerland) is a new transcatheter aortic valve designed for transapical implantation. The six-month results from the completed first-in-man study are reported. METHODS The Symetis ACURATE TA(™) is composed of a porcine biological tissue valve attached to a self-expandable nitinol stent. It allows for anatomical orientation and facilitates intuitive implantation providing tactile feedback. Since November 2009, a total of 40 high-risk elderly patients have been treated. RESULTS The mean age of enrolled patients was 83.2 ± 4.0; 60.0% were female, with a mean logistic EuroSCORE of 21.2 ± 10.8% and a mean Society of Thoracic Surgeons (STS) score of 9.0 ± 4.7%. All implants were delivered successfully in the intra-annular and subcoronary position. One patient was converted to conventional surgery due to coronary impingement (after valve-in-valve implantation). One additional patient received valve-in-valve treatment (SAPIEN THV TA(™)). Five patients expired within 30 days and two additional patients expired during the 6-month follow-up due to non-valve-related causes resulting in a mid-term survival rate of 82.5%. Two patients suffered a stroke and another three required new onset pacemaker implantation. The mean aortic gradient significantly improved and remained stable throughout the follow-up (baseline: 51.9 ± 14.3 mmHg, 30 days: 12.3 ± 5.1 mmHg, 6 months: 11.9 ± 5.8 mmHg). At the 6-month follow-up, 96.7% of patients demonstrated either none/trace or mild (1+/4) paravalvular leakage only. According to the Valve Academic Research Council the devices success rate was 92.5%, with a 30-day safety profile of 25%. CONCLUSIONS At the 6-month follow-up, the ACURATE TA(™) device showed stable valve function with low rates of paravalvular leakages. The cohort of high-risk patients demonstrated good clinical outcomes and 6-month survival.

Trans-apical aortic valve implantation using a new self-expandable bioprosthesis: initial outcomes §

OBJECTIVE Trans-apical aortic valve implantation (TA-AVI) has evolved into a standard approach for high-risk, elderly patients using the balloon-expandable Edwards SAPIEN™ prosthesis. As an alternative device, a self-expanding sub-coronary trans-apical bioprosthesis was evaluated. METHODS The Symetis Acurate™ trans-catheter heart valve is composed of a porcine biologic valve attached to a self-expandable nitinol stent. It allows for anatomical orientation, and facilitates intuitive implantation providing tactile feedback. Three valves sizes were available to treat patients with an annular diameter between 21 and 27mm. RESULTS Since November 2009, a total of 40 patients have been treated at three sites. Patient age was 82.8±4 years, 60% were female, logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 21.5±10.9% and Society of Thoracic Surgeons (STS) Score was 9.0±4.6%. All implants were delivered successfully in the intra-annular and sub-coronary position off pump. One patient was converted to conventional surgery due to coronary impingement; post-dilatation was performed in 45% of patients; and two patients required the SAPIEN™ valve in valve implantation. Echocardiographic and angiographic control revealed no/trivial aortic incompetence (AI) in 59%, mild AI in 33.3%, and moderate AI in 7.7% of the patients. Three patients died within 30 days from a non-valve-related cause (respiratory), the patient converted did not recover from right-heart failure, and one patient died on day 19 due to unclear reasons. There was one incidence of new-onset atrioventricular (AV) block requiring pacemaker implantation. Two patients suffered a stroke (one secondary and the other intraprocedural). Transvalvular gradients were maximum 29.4±10.7mmHg and mean 14.3±6.8mmHg. CONCLUSION The initial clinical results indicate a relatively straightforward implantation procedure and good functional results after trans-apical implantation of the Symetis Acurate™ device.

Two-year survival of patients screened for transcatheter aortic valve replacement with potentially malignant incidental findings in initial body computed tomography

Aims Recently, transcatheter aortic valve replacement (TAVR) has evolved as the standard treatment in patients with inoperable aortic valve stenosis. According to TAVR guidelines, body computed tomography (CT) is recommended for pre-procedural planning. Due to the advanced age of these patients, multiple radiological potentially malignant incidental findings (pmIFs) appear in this cohort. It is unknown how pmIFs influence the decision by the heart team to intervene and the mortality. Methods and results We evaluated in a retrospective single-centre observational study 414 participants screened for TAVR with dual-source CT between October 2010 and December 2012. pmIFs are common and appeared in 18.7% of all patients screened for TAVR. The decision to intervene by TAVR or surgical aortic valve replacement (SAVR) was made by an interdisciplinary heart team and the role of pmIF in decision-making and time to treatment with TAVR or SAVR was analysed, retrospectively. The appearance of a pmIF vs. no pmIF did not significantly influence therapeutic decisions [odds ratio (OR) 1.14; P = 0.835] or time to treatment (91 ± 152 vs. 61 ± 109 days, respectively). Several findings, which are highly suspicious for malignancy, were less likely associated with invasive treatment (OR 0.207; P = 0.046). Patient survival was evaluated for at least 2 years until January 2014. Two-year survival of patients after TAVR or SAVR, treated according to the heart team decision, was ∼75% and independent from the presence of a non-severe (P = 0.923) or severe (P = 0.823) pmIF. Conclusion The study indicates that frequently occurring radiologic pmIF did not influence 2-year survival after a decision to intervene was made by an interdisciplinary heart team.

Analysis of the additional costs of clinical complications in patients undergoing transcatheter aortic valve replacement in the German Health Care System

BACKGROUND This study aims at analyzing complication-induced additional costs of patients undergoing transcatheter aortic valve replacement (TAVR). METHODS In a prospective observational study, a total of 163 consecutive patients received either transfemoral (TF-, n=97) or transapical (TA-) TAVR (n=66) between February 2009 and December 2012. Clinical endpoints were categorized according to VARC-2 definitions and in-hospital costs were determined from the hospital perspective. Finally, the additional costs of complications were estimated using multiple linear regression models. RESULTS TF-TAVR patients experienced significantly more minor access site bleeding, major non-access site bleeding, minor vascular complications, stage 2 acute kidney injury (AKI) and permanent pacemaker implantation. Total in-hospital costs did not differ between groups and were on average €40,348 (SD 15,851) per patient. The average incremental cost component of a single complication was €3438 (p<0.01) and the estimated cost of a TF-TAVR without complications was €34,351. The complications associated with the highest additional costs were life-threatening non-access site bleeding (€47,494; p<0.05), stage 3 AKI (€20,468; p<0.01), implantation of a second valve (€16,767; p<0.01) and other severe cardiac dysrhythmia (€10,611 p<0.05). Overall, the presence of complication-related in-hospital mortality increased costs. CONCLUSIONS Bleeding complications, severe kidney failure, and implantation of a second valve were the most important cost drivers in our TAVR patients. Strategies and advances in device design aimed at reducing these complications have the potential to generate significant in-hospital cost reductions for the German Health Care System.

Stenosed Quadricuspid Aortic Valve Treated by Transcatheter Aortic Valve Implantation

![Figure][1] [![Graphic][3] ][3][![Graphic][4] ][4] A 79-year-old woman with known severe aortic stenosis and concomitant moderate aortic regurgitation underwent transesophageal echocardiography and electrocardiographically gated cardiac computed tomographic angiography for

TAVI 2012: state of the art

The development of “transcatheter aortic valve implantation (TAVI)” is changing the field of cardiovascular medicine rapidly. The basic principle of TAVI is the percutaneous implantation of a bioprosthesis mounted in a metal frame. The prosthesis, which is attached to the tip of the catheter, is positioned in the native aortic valve and expanded. The first successful implantation was made by Alain Cribier in 2002. Several smaller mono- and multicenter studies later confirmed the technical feasibility of this procedure. Its true value as an important, therapeutic alternative to open heart surgery in inoperable and high-risk patients is now confirmed in large multicenter registries and by the prospective, randomized PARTNER trial. Decisive for the future acceptance of the procedure and for a possible expansion of the indication spectrum will be (1) continuous further development of the implantation technique and the prosthesis design, (2) reduction of TAVI-associated complications, (3) confirmation of the initial positive long-term results and (4) confirmation of the promising results in the treatment of surgical prosthesis dysfunctions and of patients with low to intermediate risk.

The COSTA Study: Sternal Closure in High-Risk Patients - A Prospective Randomized Multicenter Trial

Background Median sternotomy in patients with risk factors for wound healing is associated with high rates of postoperative wound infections and sternum instability. Methods A total of 338 patients with elective first median sternotomy and at least four predefined risk factors were randomized between Sternal Talon (Gebrüder Martin GmbH & Co. KG—KLS Martin Group, Tuttlingen, Germany) and wire cerclage. The primary end point was mediastinitis and/or sternal instability within 30 ± 5 days, and the secondary end points were mediastinitis and/or sternal instability within 60 ± 5 days; incidence of pneumonia during hospitalization within the first 30 (±5) days and chest pain intensity. Results The primary end point was reached in 10 Sternal Talon and 7 wire cerclage patients (6.2 vs. 4.7%, odds ratio [OR]: 1.3, 95% confidence interval [CI]: 0.5‐3.6, p = 0.57) from 338 randomized patients. Sternal Talon group, n = 170 patients versus wire cerclage group, n = 168 patients. The differences between treatment groups with regard to the incidence of mediastinitis/sternum instability within the first 60 (±5) days after the primary sternum closure and the incidence of pneumonia during the hospitalization within the first 30 (±5) days were not statistically significant, either. We observed comparable rates of superficial surgical site infection (SSI) in Sternal Talon and wire cerclage patients (16.1 vs. 12.1%, OR: 1.4, 95% CI: 0.7‐2.7, p = 0.31). Conclusion According to these data, there is no statistically significant difference between Sternal Talon closure and wire cerclage in reducing the incidence of mediastinitis and superficial SSI after primary closure of median sternotomy in high‐risk patients.

The permanent jarvik 2000 - a new therapeutic option for cardiac amyloidosis

Heart involvement is the most important prognostic factor determining survival in systemic amyloidosis. Cardiac transplantation in these patients may result in graft loss due to rapid deposition of amyloid in the donor heart. With respect to the shortage of donor organs the search for alternative therapeutic approaches is of major concern. We explored the use of a new type of LVAD intended as long-term solution to end-stage heart failure. The Jarvik 2000, an intraventricular axial pump, was implanted in a 64 years old man with end stage heart failure (NYHA class IV) due to cardiac amyloidosis. The device is available in a version for permanent support with the power cable via a skull-mounted pedestal. The pump can generate a non-pulsatile flow up to 6 l/min. The postoperative course was uneventful. Weaning from respirator was possible after 14 hours. Inotropic support was required for 3 days. There have been no signs of significant hemolysis and no device-related complications. Nine weeks after implantation of the device, symptoms of heart failure have resolved and the patient has improved to NYHA functional class II. He has been completely mobilized and exercise capacity has continuously increased. To day, amyloidosis has not involved extracardiac organs. According to the first clinical experience, permanent left ventricular support using the Jarvik 2000 seems to be a promising new therapeutic approach for cardiac amyloidosis. Long term prognosis will be determined by the progression of amyloidosis and the reliability of the assist system.