Antonia Schulz

Preliminary Results From the C-Pulse® OPTIONS HF European Multicenter Post-Market Study

Background The C-Pulse® System is an extra-aortic balloon counterpulsation device. It is used to treat patients with heart failure disease in NYHA functional class III or ambulatory class IV. Material/Methods We present preliminary site-reported 6-month data from 3 centers in Germany as part of the prospective observational post-market OPTIONS HF study. Results Between May 2013 and March 2014, the C-Pulse System was implanted in 8 patients (7 male) with a mean age of 61.6±9.3 years. Four had ischemic and 4 had non-ischemic cardiomyopathy. No stroke, myocardial infarction, major bleeding, or major infection due to the device were reported. One patient developed non-device-related refractory tachycardia with worsening heart failure 12 h after surgery and underwent left ventricular assist device implantation. Within 6 months of observation, functional status improved from NYHA III to II in 5 patients, and 2 remained in NYHA III. Mean left ventricular ejection fraction increased from 24.3±7.9% to 44.5±4.5% (p<0.0001). Mean Kansas City Cardiomyopathy Questionnaire overall score improved from 28.6±19.1 to 59.1±22.5 (p=0.0183). Six-minute walk test was performed in 6 out of 7 patients at follow-up. The mean distance improved from 252.0±85.1 m to 279.2±87.5 m (p>0.05). One patient was weaned off the device after 6 months of support. Conclusions The C-Pulse System provides a therapeutic option for patients with moderate-to-severe heart failure and seems to improve quality of life and cardiac function over time.

Extraanatomic Bypass Technique for the Treatment of Midaortic Syndrome in Children

BACKGROUND This report aims to introduce the extraanatomic bypass technique to treat the midaortic syndrome and to document its long-term effectiveness and durability. METHODS Fourteen patients (mean age, 6.7 ± 3.76 years; range 8 months to 11 years) received diagnoses of midaortic syndrome, characterized by severe narrowing of the abdominal aorta with involvement of the renal and visceral branches. Angiography showed variable lengths of high-grade midaortic stenosis, with 7 children having visceral artery involvement and 9 having renal artery involvement. All children were hypertensive (mean blood pressure, 165 ± 15.7 mm Hg). Three had had previous nephrectomies. Six patients had had previous percutaneous transluminal renal artery angioplasties. The midaortic obstruction was relieved by descending abdominal aorta bypass (left thoracoabdominal approach) and by an ascending abdominal aorta bypass (median sternotomy and transabdominal approach) in 12 patients. No visceral artery revascularization was done. RESULTS There was a considerable blood pressure reduction in all patients and relief of intermittent claudication in 6 affected patients. One patient had a bilateral renal artery bypass 2 weeks postoperatively because of recurrence of renal hypertension. At a mean follow-up time of 5.8 ± 1.36 years (range, 9 months to 15 years), there was no further reoperation nor mortality. Twelve patients had complete relief of hypertension, and 2 had mild hypertension. All patients have normal renal function and no signs or symptoms of visceral malperfusion. Growth and development have proceeded normally. Follow-up magnetic resonance tomography showed patent grafts without any strictures. CONCLUSIONS Extraanatomic bypass provides very effective and long-term relief of hypertension and any malperfusion in midaortic syndrome.

HeartMate 3 implantation via left lateral thoracotomy with outflow graft anastomosis to the descending aorta

The HeartMate 3 (Thoratec Corp, Pleasanton, CA) is the first commercially approved intrapericardial centrifugal-flow left ventricular assist device (LVAD) that uses a fully magnetically levitated rotor. It is usually implanted via median sternotomy. The device received Conformité Européene Mark approval after meeting the primary end point of the Conformité Européene Mark clinical trial with a survival rate of 92% in October 2015. The trial also showed low adverse event rates during the 6 month follow-up period, and so far, no pump thrombosis has been reported. We report the implantation of the HeartMate 3 device via left lateral thoracotomy with outflow graft anastomosis to the descending aorta to avoid redo sternotomy. A 46-year-old man with end-stage dilated cardiomyopathy was admitted to our hospital with decompensated heart failure. He was previously evaluated for heart transplantation but transplantation was contraindicated due to pulmonary hypertension. His medical history also included MitraClip (Abbott) implantation for severe mitral insufficiency 2.5 years earlier. Intraoperatively, the wire perforated the left atrium so that median sternotomy was performed for surgical repair. After admission the patient showed an increasing demand for inotropic therapy and agreed to LVAD implantation. The left ventricular ejection fraction was 11% to 13%. He was classified as Interagency Registry for Mechanically Assisted Circulatory Support Profile 3. Because of the previous surgery and the expected degree of adhesions, we decided to implant the HeartMate 3 LVAD via a left lateral approach. The patient was intubated with a double-lumen endotracheal tube and was placed in a 451 right lateral position. Left lateral thoracotomy was performed in the sixth intercostal space, and the apex was freed of adhesion with removal of the pericardium from the apex. Femoral-femoral cardiopulmonary bypass (CPB) was initiated with systematic heparinization, and ventilation of the left lung was stopped. The pulmonary ligament was divided and the descending aorta exposed. The outflow graft was trimmed for length and anastomosed to the tangentially clamped

No indication for an unexpected high rate of coronary artery aneurysms after angioplasty with drug-coated balloons.

AIMS Coronary artery aneurysms (CAA) are a rare complication after percutaneous coronary intervention (PCI) and are reported with an incidence of 0.6% to 3.9%. While in recent years the use of paclitaxel drug-coated balloons (DCB) has increased, so far no CAA formation after DCB intervention has been reported. METHODS AND RESULTS During the years 2010 and 2011 we used DCBs in 704 PCIs. Follow-up angiography was scheduled at four months in all patients and has so far been achieved in 380 PCIs. In three patients we found development of a CAA at the former PCI site within four months of observation. Aneurysm length varied between 8.4 mm and 13 mm and lumina increased 58% to 131%. Retrospectively all patients with CAA development showed small intimal dissection partially with tiny persisting contrast bands parallel to the lumen according to type B and type C of the NHLBI classification after PCI. CONCLUSIONS CAA formation after DCB intervention was found in three out of 380 PCIs with DCB, consistent with an incidence of 0.8%. Thus, PCI with DCB does not cause an unexpectedly high rate of coronary artery aneurysms.

Possible spontaneous PFO closure after thrombus trapped in PFO

Sirs: Up to 30 % of the population have a patent foramen ovale (PFO) caused by defective fusion of the septum primum coverage of the fossa ovalis area after birth. Clinical Research in Cardiology has reported repeatedly on various aspects of PFOs [1–14]. While a gradual decrease in the prevalence of PFOs with increasing age has been convincingly shown, the reason for this has only been speculated on [15, 16]. We report a case with spontaneous closure of a PFO due to thrombus dislodgement and trapping. A 62-year-old male was admitted to hospital with decompensated heart failure, atrial flutter and heart rate 120 bpm. Due to the initial inadequate response to betablockers, cardioversion was prepared. The pre-cardioversion transesophageal echocardiogram (TEE) showed a typical PFO morphology with an 18 mm tunnel and a floating thrombus in the PFO, parts of it clearly hanging out into the left atrium (Fig. 1). No other relevant findings were disclosed, with the left atrial appendage (LAA) being free of thrombi. Due to the intraatrial thrombus, no cardioversion was performed, enoxaparin was replaced by dabigatran and the heart rate controlled by beta-blockers and digitoxin. Five days after admission, the patient experienced a transitory ischemic attack (TIA) with aphasia for 1 h. The workup for cardioembolic or aortoembolic causes revealed no signs of atheromatous disease of ascending and descending aorta or the carotid arteries. So, embolism from the thrombus trapped in the PFO was judged to be the most likely reason for the TIA. The further course was uneventful and the patient was discharged. He was restudied with TEE after 6 weeks showing complete resolution of the thrombus in the PFO area (Fig. 2). No new neurologic symptoms had occurred, he was in sinus rhythm and no thrombus was found in the LAA. He was readmitted 6 months after the initial hospitalization for planned PFO closure. TEE with contrast injection (Gelafundin ) showed no bubbles appearing in LA or passing the PFO channel. For additional proof, the patient was taken to the cardiac catheterization laboratory. The PFO could not be passed by a 6 F and a 5 F multipurpose catheter. Under TEE guidance, the fossa ovalis was probed and the catheter placed in the tunnel so that the septum primum was tented. Contrast was injected directly with the catheter onto the fossa ovalis and no bubbles appeared in LA. Thus, it was concluded that at this point of time the formerly open PFO had spontaneously closed. Morbidity due to patent foramen ovale is known for almost 25 years. Over 50 patients have been reported in the literature on thrombi caught ‘‘in flagranti’’ in the PFO [17]. This report is to the best of our knowledge the first case that presented with a spontaneous PFO closure in adulthood. One case reported by Zerio was interpreted differently: The apparent lack of shunt detection after resolution of the thrombus and resolution of pulmonary hypertension after thrombolysis of an accompanying pulmonary embolism were interpreted as a ‘‘functional PFO closure’’ since a ‘‘loss of the fixed convexity’’ of the interatrial septum was observed simultaneously [18]. Our patient had a rather long tunnel which was initially filled with thrombus with a part A. Schulz T. Hauschild F. X. Kleber (&) Charité University Medicine Berlin, Unter den Linden 21, 10117 Berlin, Germany e-mail: fxk@gmx.eu

Epidemiology of Myocardial Infarction Caused by Presumed Paradoxical Embolism via a Patent Foramen Ovale

BACKGROUND Despite several negative prospective randomized trials on the efficacy of patent foramen ovale (PFO) occlusion, the discussion on indications is ongoing. Because the incidence of paradoxical coronary embolism through a PFO is unknown, we investigated the risk of paradoxical embolic myocardial infarction over a period of 13 years.Methods and Results:We conducted a retrospective and a prospective study. In the former, we searched the hospital database of a tertiary referral center for cases of acute myocardial infarction (AMI) during the past 10 years and screened them for possible paradoxical MIs. On this basis we started a prospective evaluation over 39 months in another tertiary referral center. All patients with AMI and normal coronary arteries were screened for PFO and if no other reason for the AMI could be found, the case was judged as presumed paradoxical embolism. In the retrospective analysis we found 22 cases (0.45%) of presumed paradoxical coronary artery embolism under 4,848 AMI. In the prospective study there were 11 presumed paradoxical coronary artery embolisms among 1,654 patients with AMI, representing an incidence of 0.67%. CONCLUSIONS Our findings demonstrated that well below 1% of AMIs are caused by paradoxical embolism via an interatrial communication. Although this percentage appears low, it is not a negligible number of patients based on the huge number of MIs occurring in the industrialized world.

Assessment of a congenital heart surgery programme: a reappraisal

OBJECTIVES To assess our practice according to the Society of Thoracic Surgeons and the European Association for Cardio-Thoracic Surgery (STS-EACTS) Mortality Score and to the new concept of unit performance. METHODS All main procedures carried out in the years 2012-2016 were analysed. The STS-EACTS model-based mortality risk procedure was used to calculate expected mortality. Surgical performance was estimated as the Aristotle complexity score multiplied by hospital survival. Unit performance was defined as surgical performance multiplied by the number of procedures. RESULTS In total, 2435 procedures were analysed. One hundred and two deaths (95% confidence interval 71-135 deaths) were expected; 43 patients died after operation. Observed mortality divided by expected mortality was 0.42. The ratio ranged from 0.23 (year 2014) to 0.59 (year 2013) and was <0.6 in all STS-EACTS mortality categories. The difference between observed and expected mortality was highly significant: 1.8% vs 4.2% (P-value <0.0001). Observed surgical and unit performances were, higher than expected performances every year. Achieved surgical performance was the highest in year 2012 (7.28 ± 2.54) and the lowest in year 2014 (7.04 ± 2.52). The highest figure of unit performance was achieved in year 2016: 3980 points. CONCLUSIONS The STS-EACTS score, currently recognized as a sound instrument to assess mortality after congenital heart surgery, overestimated postoperative mortality. If these results are confirmed by other centres, the model should be recalibrated to match the current surgical practice. Although surgical performance can evaluate outcome quality, it does not include case volume activity. Unit performance provides this information, and it integrates quality and quantity into a single value.

Results of aortic valve repair using decellularized bovine pericardium in congenital surgery

OBJECTIVES The search for an optimal patch material for aortic valve reconstruction (AVR) is an ongoing challenge. In this study, we report our experience of AVR using decellularized bovine pericardial patch material in congenital heart surgery. METHODS Data of 40 consecutive patients who underwent AVR using the CardioCel® patch (Admedus Regen Pty Ltd, Perth, WA, Australia) between February 2014 and August 2016 were retrospectively reviewed. The median age of the patients at operation was 9 (2-34) years, and 18 patients were younger than 7 years. Twenty-six patients initially presented with aortic valve insufficiency (AI) and 14 with stenosis. Clinical and echocardiographic data were available until August 2017 for a median postoperative follow-up (FU) of 22 (6-42) months. RESULTS Nine of 40 (23%) patients experienced an event during FU (death: n = 1, 2.5%; reoperation: n = 8, 20%). Overall, the probability of freedom from reoperation or death was 97 ± 3%, 76 ± 9% and 57 ± 12% at 12, 24 and 36 months of FU, respectively. Reason for reoperation was stenosis in 3 (37.5%) patients, insufficiency in 4 (50%) patients and 1 (12.5%) patient was diagnosed with aortic valve endocarditis. Of the remaining 31 patients, 2 patients are scheduled for reoperation (aortic valve stenosis: n = 1 and AI: n = 1) and 9 patients exhibit worsening of aortic valve function with moderate AI. Freedom from developing combined end point [death/reoperation/moderate degree of aortic valve dysfunction (aortic valve stenosis, AI)] after AVR was 92 ± 5%, 55 ± 9% and 28 ± 9% at 12, 24 and 36 months, respectively. CONCLUSIONS AVR using decellularized bovine pericardial patch material in patients with congenital aortic valve disease show unsatisfactory results within the first 3 years of FU.

Reply to the correspondence on “Possible spontaneous PFO closure after thrombus trapped in PFO”, Antonia Schulz et al., Clin Res Cardiol 2014; 103:333–335

We thank the authors for their important contribution. We briefly alluded to this pathophysiology in our discussion and regret that we have quoted the authors and not discussed this in more detail, simply because of constraints in space. However, as the attached picture shows, the structure clearly protruded into the right atrial opening of the channel and was therefore not interpreted as a local thrombus formation. The different appearance of the right atrial opening before and after thrombus disappearance do underscore our interpretation.