Sebastian Völz

Blood pressure changes after renal denervation at 10 European expert centers

We did a subject-level meta-analysis of the changes (Δ) in blood pressure (BP) observed 3 and 6 months after renal denervation (RDN) at 10 European centers. Recruited patients (n=109; 46.8% women; mean age 58.2 years) had essential hypertension confirmed by ambulatory BP. From baseline to 6 months, treatment score declined slightly from 4.7 to 4.4 drugs per day. Systolic/diastolic BP fell by 17.6/7.1 mm Hg for office BP, and by 5.9/3.5, 6.2/3.4, and 4.4/2.5 mm Hg for 24-h, daytime and nighttime BP (P⩽0.03 for all). In 47 patients with 3- and 6-month ambulatory measurements, systolic BP did not change between these two time points (P⩾0.08). Normalization was a systolic BP of <140 mm Hg on office measurement or <130 mm Hg on 24-h monitoring and improvement was a fall of ⩾10 mm Hg, irrespective of measurement technique. For office BP, at 6 months, normalization, improvement or no decrease occurred in 22.9, 59.6 and 22.9% of patients, respectively; for 24-h BP, these proportions were 14.7, 31.2 and 34.9%, respectively. Higher baseline BP predicted greater BP fall at follow-up; higher baseline serum creatinine was associated with lower probability of improvement of 24-h BP (odds ratio for 20-μmol l−1 increase, 0.60; P=0.05) and higher probability of experiencing no BP decrease (OR, 1.66; P=0.01). In conclusion, BP responses to RDN include regression-to-the-mean and remain to be consolidated in randomized trials based on ambulatory BP monitoring. For now, RDN should remain the last resort in patients in whom all other ways to control BP failed, and it must be cautiously used in patients with renal impairment.

Hyperresponders vs. nonresponder patients after renal denervation: do they differ?

Background: Blood pressure (BP) response after renal denervation (RDN) is highly variable. Besides baseline BP, no reliable predictors of response have been consistently identified. The differences between patients showing a major BP decrease after RDN vs. nonresponders have not been studied so far. Aim and methods: We identified extreme BP responders (first quintile) and nonresponders (fifth quintile) to RDN defined according to office or 24-h ambulatory BP in the European Network COordinating research on Renal Denervation database (n = 109) and compared the baseline characteristics and BP changes 6 months after RDN in both subsets. Results: In extreme responders defined according to ambulatory BP, baseline BP and BP changes 6 months after RDN were similar for office and out-of-the office BP. In contrast, extreme responders defined according to office BP were characterized by a huge white-coat effect at baseline, with dramatic shrinkage at 6 months. Compared with nonresponders, extreme responders defined according to office BP were more frequently women, had higher baseline office – but not ambulatory – BP, and higher estimated glomerular filtration rate (eGFR). In contrast, when considering ambulatory BP decrease to define extreme responders and nonresponders, the single relevant difference between both subsets was baseline ambulatory BP. Conclusion: This study suggests a major overestimation of BP response after RDN in extreme responders defined according to office, but not ambulatory BP. The association of lower eGFR with poor response to RDN is consistent with our previous analysis. The increased proportion of women in extreme responders may reflect sex differences in drug adherence.

Acute tamponade of the left paracorporeal pump house due to membrane defect in a patient with a Berlin Heart EXCOR © biventricular assist device

We report a case of acute tamponade of the left paracorporeal pump house in a patient supported by a Berlin Heart EXCOR biventricular assist device (BiVAD) caused by mechanical defect in the membrane of the arterial chamber. A 36-year old male was admitted for composite graft surgery due to a large aortic regurgitation and consecutive heart failure, decompensated postoperatively and was rescued by with an extracorporeal membrane oxygenation (ECMO) device. He was accepted for heart transplantation, and a BiVAD (Berlin Heart EXCOR) was implanted as bridge-to-transplantation. Two months after discharge, he experienced dyspnoea and received error signals from his BiVAD. Relatives released him from his BiVAD companion driver, connected him to the hand pump and transported him to our institution. On arrival, he was in cardiogenic shock and was stabilized by ECMO. Inspection of the arterial chamber revealed a wear hole and delamination of the diaphragm, which had led to a tamponade by air insufflation into the three-layer membrane. New BiVAD paracorporeal pumps were connected, and the patient was subsequently successfully transplanted. The case depicts the difficulty of diagnosis in this specific patient setting. Despite transparent design of the BiVAD chambers, the development of a chamber tamponade remained undetected until explantation of the system.

Effect of catheter-based renal sympathetic denervation on 24-h ambulatory blood pressure in patients with resistant hypertension.

Abstract We investigated the effect of renal denervation on office blood pressure (OBP) and 24-h ambulatory blood pressure (BP) measurement (ABPM) at baseline and 6 months after intervention in 25 consecutive patients with resistant hypertension. Mean baseline 24-h ABPM and OBP were 158/88 mmHg and 169/96 mmHg, respectively. Patients were treated with an average of 4 ± 1 antihypertensive drugs. Among the 22 patients included in data analysis, mean ambulatory systolic and diastolic BP were reduced by 6 mmHg from 158 ± 17 to 152 ± 20 mmHg (p < 0.05) and by 3 mmHg from 88 ± 12 to 85 ± 14 mmHg (p = ns) after 6 months follow-up, respectively. Blood pressure reduction was most pronounced during daytime with a decrease of 9 mmHg from 164 ± 17 to 155 ± 19 (p < 0.05) in systolic (SBP) and 6 mmHg from 94 ± 14 to 88 ± 14 mmHg in diastolic BP (DBP) (p < 0.05). Night-time SBP mmHg and DBP were similar at baseline compared with follow-up. Systolic and diastolic OBP during follow-up were significantly reduced by 17 mmHg from 169 ± 20 to 152 ± 21 (p < 0.05) and by 9 mmHg from 96 ± 16 to 87 ± 13 mmHg (p < 0.05), respectively. These results provide new insight into the effect of renal denervation on ABPM day- and night-time blood pressure profile in comparison with OBP. The decrease in ABPM was identified during daytime registration and was less pronounced compared with reduction of OBP.

Hypertension is associated with increased mortality in patients with ischaemic heart disease after revascularization with percutaneous coronary intervention - a report from SCAAR.

Abstract Background: The prognostic role of hypertension on long-term survival after percutaneous coronary intervention (PCI) is limited and inconsistent. We hypothesize that hypertension increases long-term mortality after PCI. Methods: We analyzed data from SCAAR (Swedish Coronary Angiography and Angioplasty Registry) for all consecutive patients admitted coronary care units in Sweden between January 1995 and May 2013 and who underwent PCI due to ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (NSTEMI)/unstable angina (UA) or stable angina pectoris. We used Cox proportional-hazards regression for statistical modelling on complete-case data as well as on imputed data sets. We used interaction test to evaluate possible effect-modulation of hypertension on risk estimates in several pre-specified subgroups: age categories, gender, diabetes, smoking and indication for PCI (STEMI, NSTEMI/UA and stable angina). Results: During the study period, 175,892 consecutive patients underwent coronary angiography due to STEMI, NSTEMI/UA or stable angina. 78,100 (44%) of these had hypertension. Median follow-up was 5.5 years. After adjustment for differences in patient’s characteristics, hypertension was associated with increased risk for mortality (HR 1.12, 95% CI 1.09–1.15, p < .001). In subgroup analysis, risk was highest in patients less than 65 years, in smokers and in patients with STEMI. The risk was lowest in patients with stable angina (p < .001 for interaction test). Conclusion: Hypertension is associated with higher mortality in patients with STEMI, NSTEMI/UA or stable angina who are treated with PCI.

Bivalirudin versus heparin monotherapy in non-ST-segment elevation myocardial infarction

Background: The optimal anti-coagulation strategy for patients with non-ST-elevation myocardial infarction treated with percutaneous coronary intervention is unclear in contemporary clinical practice of radial access and potent P2Y12-inhibitors. The aim of this study was to investigate whether bivalirudin was superior to heparin monotherapy in patients with non-ST-elevation myocardial infarction without routine glycoprotein IIb/IIIa inhibitor use. Methods: In a large pre-specified subgroup of the multicentre, prospective, randomised, registry-based, open-label clinical VALIDATE-SWEDEHEART trial we randomised patients with non-ST-elevation myocardial infarction undergoing percutaneous coronary intervention, treated with ticagrelor or prasugrel, to bivalirudin or heparin monotherapy with no planned use of glycoprotein IIb/IIIa inhibitors during percutaneous coronary intervention. The primary endpoint was the rate of a composite of all-cause death, myocardial infarction or major bleeding within 180 days. Results: A total of 3001 patients with non-ST-elevation myocardial infarction, were enrolled. The primary endpoint occurred in 12.1% (182 of 1503) and 12.5% (187 of 1498) of patients in the bivalirudin and heparin groups, respectively (hazard ratio of bivalirudin compared to heparin treatment 0.96, 95% confidence interval 0.78–1.18, p=0.69). The results were consistent in all major subgroups. All-cause death occurred in 2.0% versus 1.7% (hazard ratio 1.15, 0.68–1.94, p=0.61), myocardial infarction in 2.3% versus 2.5% (hazard ratio 0.91, 0.58–1.45, p=0.70), major bleeding in 8.9% versus 9.1% (hazard ratio 0.97, 0.77–1.24, p=0.82) and definite stent thrombosis in 0.3% versus 0.2% (hazard ratio 1.33, 0.30–5.93, p=0.82). Conclusion: Bivalirudin as compared to heparin during percutaneous coronary intervention for non-ST-elevation myocardial infarction did not reduce the composite of all-cause death, myocardial infarction or major bleeding in non-ST-elevation myocardial infarction patients receiving current recommended treatments with modern P2Y12-inhibitors and predominantly radial access.

Effect of renal denervation on coronary flow reserve in patients with resistant hypertension

Renal denervation (RDN) is a potential modality in the treatment of patients with resistant hypertension (RH) and has shown beneficial effect on a variety of cardiovascular surrogate markers. Coronary flow reserve, as assessed by transthoracic Doppler echocardiography (TDE‐CFR) is impaired in patients with hypertension and is an independent predictor of cardiac morbidity. However, data on the effect of RDN on TDE‐CFR are scarce. The main objective of this study was to assess the effect of RDN on TDE‐CFR. Twenty‐six consecutive patients with RH (9 female and 17 male; mean age 62 ± 8 years; mean number of antihypertensive drugs 4·2 ± 1·6) underwent bilateral RDN. CFR was assessed at baseline and 6 months after intervention. Mean flow velocity was measured in the left anterior descending artery by transthoracic Doppler echocardiography at baseline and during adenosine infusion (TDE‐CFR). Systolic office blood pressure was reduced at follow‐up (174 ± 24 versus 162 ± 27 mmHG; P = 0·01). Mean systolic ambulatory blood pressure decreased from 151 ± 21 to 147 ± 18 (P = 0·17). TDE‐CFR remained unchanged 6 months after intervention (2·7 ± 0·6 versus 2·7 ± 0·7; P = 0·67). In conclusion, renal denervation was not associated with any changes in regard to coronary flow reserve at 6‐month follow‐up.

Prognosis is similar for patients who undergo primary PCI during regular‐hours and off‐hours: A report from SCAAR*

Timely percutaneous coronary intervention (PCI) improves prognosis in ST‐elevation myocardial infarction (STEMI). However, recent reports indicate that patients with STEMI who present during non‐regular working hours (off‐hours) have a worse prognosis. The aim of this study was to compare outcome between patients with STEMI who underwent primary PCI during off‐hours and regular hours.

Sustained risk of stent thrombosis and restenosis in first generation drug-eluting Stents after One Decade of Follow-up: A Report from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR)

Long‐term comparisons between Drug‐eluting stent and bare metal stent are not well‐studied. The aim of this study was to compare two stents that were previously frequently used in regard to long‐term risk of restenosis and stent thrombosis (ST).

Novel use of the AGILISTM-NxT steerable introducer-sheath in a patient with ST-elevation myocardial infarction and anomalous origin of the right coronary artery

A 60-year-old patient with no prior history of cardiovascular disease presented with chest pain, ST-elevation in the inferior leads and was referred to our centre for primary PCI. Angiography of the left coronary artery did not show any stenosis. Initial radial catherisation attempts of the right coronary artery (RCA) failed and an aortic root injection revealed an ectopic anomalous origin of the RCA arising from the left coronary sinus. Further attempts, by femoral approach, to access the vessel origin with conventional coronary guide catheters failed. Finally, a modified mother-andchild approach, by aid of the 8.5 FR medium curl steerable introducer sheath AGILIS-NxT (St. Jude Medical Inc., St. Paul, MI) in combination with a 6 FR internal mammaria artery guiding catheter, enabled selective catherisation (Figure 1: panel A). Angiography revealed a severe stenosis in the proximal segment of the RCA and two drug-eluting stents were successfully implanted (Figure 1: panel B). Subsequent cardiac computer tomography confirmed angiographic findings, showing a good stent result as well as an ectopic origin of the RCA with an intramural course between the aorta and the pulmonary artery. Coronary anomalies are found in approximately 5% of all coronary angiographies. Anomalous location of the coronary artery origin may exceed the range of conventional PCI equipment, demanding novel technical solutions. AGILIS-NxT is an introducer sheath with 8.5 FR inner lumen and a steerable sheath tip allowing for a bi-directional 180 /90 deflection, primarily designed for cardiac ablation procedures. To our knowledge, this is the first case in literature depicting AGILISNxT-facilitated PCI in an acute coronary syndrome patient with anomalous origin of the RCA. The case demonstrates the importance of familiarity with and knowledge of technical aids across the wide spectrum of interventional cardiology. Thinking ‘out-of-the-box’ by using a dedicated cardiac ablation sheath enabled successful PCI and provides an alternative access strategy in patients with coronary anomalies.