Erwin Schroeder

Prognostic value of intracoronary flow velocity and diameter stenosis in assessing the short- and long-term outcomes of coronary balloon angioplasty - The DEBATE study (Doppler Endpoints Balloon Angioplasty Trial Europe)

BACKGROUND The aim of this prospective, multicenter study was the identification of Doppler flow velocity measurements predictive of clinical outcome of patients undergoing single-vessel balloon angioplasty with no previous Q-wave myocardial infarction. METHODS AND RESULTS In 297 patients, a Doppler guidewire was used to measure basal and maximal hyperemic flow velocities proximal and distal to the stenosis before and after angioplasty. In 225 patients with an angiographically successful percutaneous transluminal coronary angioplasty (PTCA), postprocedural distal coronary flow reserve (CFR) and percent diameter stenosis (DS%) were correlated with symptoms and/or ischemia at 1 and 6 months, with the need for target lesion revascularization, and with angiographic restenosis (defined as DS > or = 50% at follow-up). Logistic regression and receiver operator characteristic curve analyses were applied to determine the prognostic cutoff value of CFR and DS separately and in combination. Optimal cutoff criteria for predictors of these clinical events were DS, 35%; CFR, 2.5. A distal CFR after angioplasty > 2.5 with a residual DS < or = 35% identified lesions with a low incidence of recurrence of symptoms at 1 month (10% versus 19%, P=.149) and at 6 months (23% versus 47%, P=.005), a low need for reintervention (16% versus 34%, P=.024), and a low restenosis rate (16% versus 41%, P=.002) compared with patients who did not meet these criteria. CONCLUSIONS Measurements of distal CFR after PTCA, in combination with DS%, have a predictive value, albeit modest for the short- and long-term outcomes after PTCA, and thus may be used to identify patients who will or will not benefit from additional therapy such as stent implantation.

Early detection of doxorubicin cardiotoxicity: Interest of Doppler echocardiographic analysis of left ventricular filling dynamics

Doxorubicin (Adriamycin) is an effective anticancer agent but its therapeutic value is limited by its myocardial cardiotoxicity. To improve early detection of doxorubicin cardiotoxicity, studies were performed in patients with long-term doxorubicin treatment using pulsed Doppler echocardiography to assess the changes in left ventricular (LV) diastolic filling dynamics. M-mode echocardiographic systolic parameters and Doppler transmitral flow velocities were analyzed in two groups of patients. In group A (45 patients, mean age 45 +/- 13 years), the results were compared with those of a control group of 35 normal subjects matched for age. In group B (19 patients, mean age 44 +/- 12 years), the pretreatment results were prospectively compared with those obtained during treatment protocol. The patients received a cumulative dosage of 253 +/- 125 mg/m2 of doxorubicin for group A and 240 +/- 135 mg/m2 for group B. After doxorubicin treatment, in the two groups there were no significant changes in LV dimensions, shortening fraction, and mean velocity of circumferential fiber shortening (VCF). In contrast, Doppler echocardiographic parameters of diastolic function were significantly modified after doxorubicin in the two groups:isovolumic relaxation period was prolonged by 32% in group A (p less than 0.001) and by 22% in group B (p less than 0.005).2+ The early peak flow velocity was reduced by 18% in group A (p less 0.002) and by 13% in group B (p less than 0.04), and the ratio early peak flow velocity/atrial peak flow velocity also decreased significantly, by 23% in group A (p less than 0.001) and by 20% in group B (p less than 0.01).(ABSTRACT TRUNCATED AT 250 WORDS)

The 2011-12 pilot European Sentinel Registry of Transcatheter Aortic Valve Implantation: in-hospital results in 4,571 patients.

AIMS The aim of this prospective multinational registry is to assess and identify predictors of in-hospital outcome and complications of contemporary TAVI practice. METHODS AND RESULTS The Transcatheter Valve Treatment Sentinel Pilot Registry is a prospective independent consecutive collection of individual patient data entered into a web-based case record form (CRF) or transferred from compatible national registries. A total of 4,571 patients underwent TAVI between January 2011 and May 2012 in 137 centres of 10 European countries. Average age was 81.4±7.1 years with equal representation of the two sexes. Logistic EuroSCORE (20.2±13.3), access site (femoral approach: 74.2%), type of anaesthesia and duration of hospital stay (9.3±8.1 days) showed wide variations among the participating countries. In-hospital mortality (7.4%), stroke (1.8%), myocardial infarction (0.9%), major vascular complications (3.1%) were similar in the SAPIEN XT and CoreValve (p=0.15). Mortality was lower in transfemoral (5.9%) than in transapical (12.8%) and other access routes (9.7%; p<0.01). Advanced age, high logistic EuroSCORE, pre-procedural ≥grade 2 mitral regurgitation and deployment failure predicted higher mortality at multivariate analysis. CONCLUSIONS Increased operator experience and the refinement of valve types and delivery catheters may explain the lower rate of mortality, stroke and vascular complications than in historical studies and registries.

Influence of balloon size and stenosis morphology on immediate and delayed elastic recoil after percutaneous transluminal coronary angioplasty

After successful coronary angioplasty, the minimal luminal diameter of the dilated coronary artery segment is generally smaller than the diameter of the largest balloon catheter at the maximal inflation pressure. The determinants of this phenomenon were studied in 28 patients. Biplane angiograms were obtained after intracoronary administration of isosorbide dinitrate (1 mg) before, immediately and 24 h after coronary angioplasty. Balloon and coronary luminal diameters were measured by automated contour detection. Immediately after the procedure, the difference between inflated balloon diameter and minimal luminal diameter averaged 0.93 +/- 0.43 mm for the entire group and was greater both in eccentric stenoses (1.13 +/- 0.39 vs. 0.70 +/- 0.36 mm; p less than 0.01) and after angioplasty with an oversized balloon (1.20 +/- 0.37 vs. 0.71 +/- 0.33 mm; p less than 0.005). At 24 h, the balloon - minimal luminal diameter difference was unchanged at the group level (0.86 +/- 0.38 mm, but the minimal luminal diameter increased significantly in the subgroup of coronary segments dilated with an oversized balloon (1.97 +/- 0.37 vs. 1.81 +/- 0.28 mm; p less than 0.05). Thus, the difference between the minimal diameter of a dilated coronary segment immediately after a successful coronary balloon angioplasty procedure and the maximal diameter of the inflated balloon catheter is dependent both on eccentricity of the stenosis and on the balloon/artery diameter ratio. Moreover, the increase in minimal luminal diameter 24 h after angioplasty performed with an oversized balloon suggest that in addition to elastic recoil partly reversible factors related to vessel barotrauma are involved.

Coronary artery bypass grafting with the inferior epigastric artery. Midterm clinical and angiographic results.

Between December 1988 and September 1993, 157 patients (141 men, 16 women, average age 60.2 years, range 37 to 78 years) underwent a complete myocardial revascularization with 157 inferior epigastric artery grafts and 285 internal mammary artery grafts (281 in situ, 4 free grafts). A total of 543 distal arterial anastomoses (average 3.4, range two to five per patient) were constructed, 376 with the internal mammary artery and 167 with the inferior epigastric artery. The inferior epigastric artery grafts were anastomosed to two left anterior descending, 5 diagonal, 34 circumflex, and 126 right coronary arteries. The indications for the use of the inferior epigastric artery were the unavailability of conventional conduits in 56 patients and a favorable anatomy or a young age in 101 selected patients. The clinical follow-up averages 31.8 months (range 6 to 62 months). Four patients died early, and there were three perioperative nonfatal myocardial infarctions. Eight patients required early reoperation for thoracic bleeding (2) or drainage of an abdominal parietal collection (6). There were four late deaths (2 sudden deaths, 2 noncardiac causes) and one nonfatal myocardial infarction. Angina recurred in nine patients, of whom one required reoperation and three underwent successful percutaneous balloon angioplasty of a native coronary artery (2) or an old saphenous vein graft (1). An early recatheterization was obtained before discharge (average 11 days) in 135 patients: 132 of 135 inferior epigastric artery grafts were patent. Seventy-seven patients underwent a second angiographic restudy 6 to 43 months after the operation. Forty-four of the 48 inferior epigastric artery grafts restudied within the first postoperative year (average 8.5 months) were patent, but eight showed a diffuse narrowing. Twenty-eight of the 29 inferior epigastric artery grafts examined angiographically between 13 and 43 months (average 25 months) were open, and among those 29, 25 were widely patent, perfectly matching the receiving coronary artery. Most of the occluded or narrowed inferior epigastric artery grafts were grafted onto coronary arteries with mild stenosis at restudy. Five patients underwent a third angiographic reexamination up to 60 months after the operation (average 39 months). All five inferior epigastric artery grafts were widely patent. The early attrition rate of the inferior epigastric artery, as for any free arterial graft, is probably the result of both the loss of a true pedicle and the need for constructing an additional proximal anastomosis. The fact that the patency rate of the inferior epigastric artery graft seems to remain stable beyond 1 year could suggest a good durability in the future.

Long-term Outcome of Patients With Asymptomatic Restenosis After Percutaneous Transluminal Coronary Angioplasty

Restenosis with recurrence of symptoms after percutaneous transluminal coronary angioplasty (PTCA) is treated in most cases by a second successful PTCA. In the case of silent restenosis in a patient previously symptomatic, the problem is less clear. Previous reports with a mean follow-up of <18 months have suggested that the prognosis of these asymptomatic patients is favorable.

Stent Thrombosis and Bleeding Complications After Implantation of Sirolimus-Eluting Coronary Stents in an Unselected Worldwide Population: A Report From the e-SELECT (Multi-Center Post-Market Surveillance) Registry

OBJECTIVES The aim of this study was to ascertain the 1-year incidence of stent thrombosis (ST) and major bleeding (MB) in a large, unselected population treated with sirolimus-eluting stents (SES). BACKGROUND Stent thrombosis and MB are major potential complications of drug-eluting stent implantation. Their relative incidence and predisposing factors among large populations treated worldwide are unclear. METHODS The SES were implanted in 15,147 patients who were entered in a multinational registry. We analyzed the incidence of: 1) definite and probable ST as defined by the Academic Research Consortium; and 2) MB, with the STEEPLE (Safety and efficacy of Enoxaparin in PCI) definition, together with their relation to dual antiplatelet therapy (DAPT) and to 1-year clinical outcomes. RESULTS The mean age of the sample was 62 ± 11 years, 30.4% were diabetic, 10% had a Charlson comorbidity index ≥3, and 44% presented with acute coronary syndrome or myocardial infarction. At 1 year, the reported compliance with DAPT as recommended by the European Society of Cardiology guidelines was 86.3%. Adverse event rates were: ST 1.0%, MB 1.0%, mortality 1.7%, myocardial infarction 1.9%, and target lesion revascularization 2.3%. Multivariate analysis identified 9 correlates of ST and 4 correlates of MB. Advanced age and a high Charlson index were associated with an increased risk of both ST and MB. After ST, the 7-day and 1-year all-cause mortality was 30% and 35%, respectively, versus 1.5% and 10% after MB. Only 2 of 13,749 patients (0.015%) experienced both MB and ST during the entire 1-year follow-up period. CONCLUSIONS In this worldwide population treated with ≥1 SES, the reported compliance with DAPT was good, and the incidence of ST and MB was low. Stent thrombosis and MB very rarely occurred in the same patient. (The e-SELECT Registry: a Multicenter Post-Market Surveillance; NCT00438919).

Local and general anaesthesia do not influence outcome of transfemoral aortic valve implantation.

BACKGROUND There is great variability for the type of anaesthesia used during TAVI, with no clear consensus coming from comparative studies or guidelines. We sought to detect regional differences in the anaesthetic management of patients undergoing transcatheter aortic valve implantation (TAVI) in Europe and to evaluate the relationship between type of anaesthesia and in-hospital and 1 year outcome. METHODS Between January 2011 and May 2012 the Sentinel European TAVI Pilot Registry enrolled 2807 patients treated via a transfemoral approach using either local (LA-group, 1095 patients, 39%) or general anaesthesia (GA-group, 1712 patients, 61%). RESULTS A wide variation in LA use was evident amongst the 10 participating countries. The use of LA has increased over time (from a mean of 37.5% of procedures in the first year, to 57% in last 6 months, p<0.01). MI, major stroke as well as in-hospital death rate (7.0% LA vs 5.3% GA, p=0.053) had a similar incidence between groups, confirmed in multivariate regression analysis after adjusting for confounders. Dividing our population in tertiles according to the Log-EuroSCORE we found similar mortality under LA, whilst mortality was higher in the highest risk tertile under GA. Survival at 1 year, compared by Kaplan-Meier analysis, was similar between groups (log-rank: p=0.1505). CONCLUSIONS Selection of anaesthesia appears to be more influenced by national practice and operator preference than patient characteristics. In the absence of an observed difference in outcomes for either approach, there is no compelling argument to suggest that operators and centres should change their anaesthetic practice.

Revascularization of the circumflex artery with the pedicled right internal thoracic artery: Clinical functional and angiographic midterm results☆☆☆★★★♢♢♢♦

Retroaortic crossing of the pedicled right internal thoracic artery for revascularization of the circumflex artery used in combination with a pedicled left internal thoracic artery anastomosed to the left anterior descending artery and its branches is an attractive technique to achieve an extensive arterial revascularization of the left ventricle. However, there is a suspicion that pulling the right internal thoracic artery through the transverse sinus could compromise its blood flow capacity and patency. Between January 1990 and July 1994 this technique was applied in 256 patients (202 men, 54 women; average age 62 years, range 31 to 80 years). Sixty-one patients had two-vessel disease and 195 had three-vessel disease. Seventeen patients were undergoing a reoperation. Twenty-two had a left ventricular ejection fraction of 40% or less. Thirty had diabetes. Twenty-eight had morbid obesity. The right internal thoracic artery was directed to the circumflex artery (259 anastomoses) through the transverse sinus and the left internal thoracic artery was anastomosed to the left anterior descending artery and its branches (375 anastomoses) in all patients. The 195 patients with three-vessel disease received additional coronary artery bypass grafts to the right coronary artery (93 saphenous vein grafts, 89 free inferior epigastric artery grafts, 12 pedicled right gastroepiploic artery grafts). In total, the 256 patients received 833 distal anastomoses (average 3.2, maximum 5 per patient) and 634 distal anastomoses were internal thoracic artery anastomoses (average 2.4, maximum 4 per patient). Three patients died early and eight had a nonfatal myocardial infarction. Seven patients needed postoperative intraaortic balloon pump support. Six patients underwent early reoperation because of excessive bleeding. Sternal dehiscence occurred in four patients. One of these four patients died of the complication 10 months after the operation. No patient was lost to follow-up (average 33 months). During follow-up, two sudden deaths and six noncardiac deaths occurred. Two patients had a nonfatal myocardial infarction and 12 had recurrence of angina. There were no late reoperations. One patient underwent a successful percutaneous balloon angioplasty of a native left anterior descending artery. Seventy-four patients, enrolled in prospective angiographic studies, underwent a postoperative recatheterization (average 13.2 months, range 6 to 58 months). Seventy-three of the 74 right internal thoracic artery grafts were patent. In comparison, 74 of 74 of the left internal thoracic artery grafts (106/107 anastomoses) were patent. Maximal stress thallium-201 scintigraphy results, obtained in 25 of those patients, did not reveal ischemia in the area of the circumflex artery.(ABSTRACT TRUNCATED AT 400 WORDS)

Pulsed Doppler intraoperative flow assessment and midterm coronary graft patency.

BACKGROUND This study was designed to assess the value of hemodynamic measurements taken intraoperatively in predicting midterm patency of coronary bypass grafts. METHODS A pulsed Doppler flowmeter was routinely used during operation to determine the hemodynamic parameters of coronary bypass grafts. During a 7-year period, 85 patients underwent angiographic evaluation. As a result, a thorough hemodynamic assessment of 214 grafts (89 arterial and 125 venous) at initial operation was available for analysis. RESULTS The overall patency rate was 88.3%. The mean flow measured intraoperatively in 168 intact grafts was 60+/-3 mL/min (range, 9 to 230 mL/min), and the resistance was 1.8+/-0.1 peripheral resistance units (range, 0.3 to 9.0 peripheral resistance units). The mean flow was 36+/-5 mL/min (range, 2 to 107 mL/min), and the resistance was 5.9+/-2.0 peripheral resistance units (range, 0.6 to 46.0 peripheral resistance units) in 25 grafts found occluded at angiographic evaluation. Multivariate analysis identified three independent variables associated with a reduced patency rate: increased resistance as measured in the graft (p = 0.012), increasing interval of control angiography (p = 0.006), and preoperative cardiogenic shock (p = 0.040). CONCLUSIONS The prognosis for midterm patency of aortocoronary bypass grafts depends on the intraoperative hemodynamic status.