Incidence, Technical Safety, and Feasibility of Coronary Angiography and Intervention Following Self-expanding Transcatheter Aortic Valve Replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a well-established treatment option for severe aortic stenosis (AS). AS and coronary artery disease frequently coincide, and therefore some patients may require coronary angiography (CAG) and/or intervention (PCI) post-TAVR. Due to valve stent design, most self-expanding prostheses always cover the coronary ostium, and therefore may hinder future access. The objective of this research was to evaluate the incidence, safety and feasibility of CAG/PCI in patients with prior self-expanding TAVR valves. METHODS: Among 2170 patients (age 82 ±â€¯6 years, 43% male) who underwent TAVR with Corevalve or Evolut prostheses, as part of the Italian CoreValve ClinicalService® framework (data from 13 Italian centers), the occurrence of CAG/PCI following TAVR and periprocedural characteristics were examined. RESULTS: During median follow-up of 379 days, 41 patients (1.9%) required CAG and/or PCI (total 46; 16 CAG, 14 PCI, 16 both PCI/CAG). 56.5% of the procedures were performed under emergency/urgency settings. Left system coronary angiography was successfully performed in most cases (28/32, 87.5%), while right coronary angiography was successful only in 50.0% (16/32). PCI procedures (20 for left system, 3 for right system, 4 for graft) were successfully performed in 93.3% (28/30) of the procedures. No CAG/PCI procedure-related complications including prosthesis dislodgment or coronary ostium dissection occurred. CONCLUSIONS: CAG and PCI procedures following CoreValve TAVR is safe and mostly feasible, although the success rate of selective right coronary angiography was relatively low when compared to the left system. Further investigations are required to explore this issue.

Two-year cardiac mortality after MitraClip treatment of functional mitral regurgitation in ischemic and non-ischemic dilated cardiomyopathy.

BACKGROUND: MitraClip implantation has evolved as a new tool for treatment of inoperable or high-risk patients with severe functional mitral regurgitation (FMR) due to dilated cardiomyopathy (DCM). Limited data are available regarding MitraClip outcomes comparing patients with ischemic and non-ischemic DCM. METHODS: From 2008 to 2016, 314 patients received MitraClip for FMR at four institutions: Brescia, Zurich and Milan. Patients were stratified according to MR aetiology in non-ischemic FMR (n = 99) and ischemic FMR (n = 215). Preoperative risk factors, operative variables and outcomes up to 2-year were evaluated. A multivariable Cox Proportional Hazards survival model with covariate adjustments was used to assess the relationship between FMR aetiology and 2-year cardiac mortality. RESULTS: As expected, patients with ischemic FMR had significantly more risk factors and comorbidities. Overall procedural success rate was 80% and in-hospital cardiac mortality was 3% without significant differences between aetiology. Two-year overall (25% vs. 19%, p = 0.574) and cardiac (18% vs. 16%, p = 0.990) mortality rates were comparable. No differences were detected in terms of re-hospitalization rates (32%), LVAD implantation (4.5%) and mitral valve surgery (1%). LVEF ≤ 25%, LVEDV > 216 ml, NT-proBNP ≥ 10.000 pg/ml and AF were the strongest baseline predictors of 2-year cardiac mortality. Greater improvements of 6MWT and NYHA functional class were observed in patients with non-ischemic FMR. CONCLUSIONS: The ischemic or non-ischemic aetiology of DCM did not affect in-hospital and 2-year cardiac mortality after MitraClip in patients with FMR. In case of unfavorable baseline clinical condition, the indication for MitraClip should be carefully weighed in favour of conservative medical therapy alone or left ventricular assist device.

Transaxillary versus transaortic approach for transcatheter aortic valve implantation with CoreValve Revalving System: insights from multicenter experience.

BACKGROUND: About one-third of candidates for transcatheter aortic valve implantation (TAVI) suffer from severe peripheral artery disease, making the routine femoral approach difficult or impossible. The aim was to compare the transaxillary (TAx) and the transaortic (TAo) route for TAVI with Medtronic CoreValve Revalving System (CRS). METHODS: Out of 1049 consecutive TAVI with 18F CRS, 242 (23%) were treated in 4 high-volume Italian Centre through TAx (61%) and TAo (39%). RESULTS: The devices success was similar (P=0.16) with a trend to a lower incidence of significant paravalvular leak (6% vs. 14%, P=0.07) and a significant reduction of permanent pacemaker (PPM) implantation (13% vs. 34%, P=0.017) in the TAo. However, this route showed a higher incidence of acute kidney injury (P=0.016) and a longer hospital stay after the index procedure (days 10 [8-14] vs. 8 [7-12], P=0.001). By a multivariate analysis the vascular access is an independent predictor for a longer hospital stay (TAo route; OR=0.37, 95% CI: 0.18-0.75; P=0.006) and for PPM implantation (TAx route; OR=3.7, 95% CI: 1.2-10.8; P=0.017). CONCLUSIONS: Although the higher clinical risk profile of transaortic population, the TAo approach showed an equally high device success with similar 30-day safety and 1year efficacy, compared to TAx route. However, due to non-procedure-specific complications post-TAo TAVI, this route requires a specialized postoperative care and the treatment of patients in highly specialized and experienced centers.

One-Year Outcomes of Transcatheter Aortic Valve Implantation Using the Direct Aortic Approach.

BACKGROUND: The direct aortic (DA) approach allows for transcatheter aortic valve implantation (TAVI) in patients with difficult peripheral vascular anatomy. The CoreValve ADVANCE Direct Aortic (ADVANCE DA) study was performed to assess the outcomes of DA TAVI with the CoreValve System (Medtronic, Minneapolis, MN) in routine practice. METHODS: Patients were selected for the DA approach by local cardiac surgical teams, and TAVI was performed with patients under general anesthesia. Safety events were adjudicated according to the Valve Academic Research Consortium-2 definitions by an independent clinical events committee. All imaging data, including that from multislice computed tomography and follow-up echocardiography, were analyzed by an independent core laboratory. RESULTS: From September 2012 to February 2014, 100 patients were enrolled (52.0% male, age 81.9 ± 5.9 years, The Society of Thoracic Surgeons Score 5.9 ± 3.2%) at 9 centers in Europe. Peripheral vascular disease was present in 51.0% of patients, and 38.0% had diabetes. Of the 100 patients enrolled, 92 underwent TAVI. At 30 days after TAVI, 98.1% were free of moderate or severe paravalvular leak. At 1 year, 16 patients had died (Kaplan-Meier rate 17.9%), 1 (1.1%) patient had had a stroke, classified as nondisabling, and 15 (17.0%) patients had received a permanent pacemaker. Most patients experienced improved quality of life as measured by the Kansas City Cardiomyopathy Questionnaire overall summary score (mean change from baseline to 1 year, 39.6 ± 26.3; p < 0.01). CONCLUSIONS: The DA approach provides a feasible alternative for patients with challenging anatomic features that may otherwise preclude use of the TAVI procedure.

The failing right heart: implications and evolution in high-risk patients undergoing transcatheter aortic valve implantation.

AIMS: Right ventricular dysfunction (RVdy) is negatively associated with survival after left heart valve surgery. It is unclear whether RVdy has the same impact in patients undergoing transcatheter aortic valve implantation (TAVI). We sought to evaluate the prognostic impact of different grades of RVdy on TAVI, with and without concomitant left ventricular dysfunction (LVdy), and the possible impact of TAVI on RVdy. METHODS AND RESULTS: Among 870 consecutive patients with severe symptomatic aortic stenosis undergoing TAVI, 226 patients (26%) presented with a concomitant diagnosis of RVdy. Patients were divided into three groups, Group 1: normal RV systolic function, i.e., tricuspid annular plane systolic excursion (TAPSE) >16 mm (n=644, 74%); Group 2: mild-to-moderate RVdy, i.e., TAPSE 10-16 mm (n=180, 20.6%); Group 3: severe RVdy, i.e., TAPSE <10 mm (n=46, 5.2%). Patients in Groups 1 and 2 showed a similar overall mortality rate at one month (5% vs. 8%, OR 1.1 [0.7-1.55], p=0.2) and at one-year follow-up (15% vs. 19%, HR 1.5 [0.84-2.2], p=0.09), respectively. Compared to Groups 1 and 2, patients in Group 3 showed a significantly higher overall mortality at one month (22%, OR 3.3 [1.8-4.1], p<0.001, and OR 2.1 [1.7-3.1], p=0.02, respectively) as well as at one-year follow-up (45%, HR 2.6 [2.1-3.45], p<0.001, and HR 1.9 [1.5-2.7], p=0.02), respectively. Pulmonary hypertension >60 mmHg (HR 1.5 [1.1-2.2], p=0.03), AF (HR 1.6 [1.1-2.4], p=0.01), creatinine clearance <30 mL/min (HR 1.92 [1.3-2.5], p=0.003), LVEF <30% (HR 1.5 [1.1-2.9], p=0.03), severe RVdy (HR 2.9 [2.7-3.3], p=0.002), severe RV dilation (HR 1.7 [1.2-2.2], p=0.005) and severe biventricular dysfunction (HR 3.9 [2.7-4.1], p=0.002) were independent predictors of one-year mortality. Among survivors, the majority of patients in Groups 2 and 3 experienced a significant improvement in NYHA class. CONCLUSIONS: Severe RVdy limits the expected benefit of TAVI. In current risk scores right heart failure is not considered. The present study advocates the evaluation of this strong predictor in a more complete pre-procedural work-up.

First-in-Man, Mitral Valve-in-Valve Transcatheter Implantation Through an Innovative Minimally Invasive Surgical Approach.

Degeneration of a surgically implanted valve bioprosthesis may occur in elderly, frail patients with an extremely high risk to undergo redo cardiac surgery. Transapical or fully percutaneous transseptal approaches have been described in order to treat degenerated aortic and mitral bioprosthesis. We performed the first-in-man successful mitral transcatheter valve delivery with a valve-in-valve technique through an innovative route; ie, a video-assisted endoscopic direct access to the left atrium, in an 82-year-old patient who previously underwent surgical replacement of the mitral valve and with a prohibitive surgical risk.

Transcatheter Aortic Valve Implantation Under Angiographic Guidance With and Without Adjunctive Transesophageal Echocardiography.

Although transcatheter aortic valve implantation (TAVI) is still currently guided by transesophageal echocardiography (TEE) in a considerable number of hospitals, exclusive angiographic (Angio) guidance seems a reasonable approach in this setting. To date, however, no studies have directly compared the outcomes of TAVI according to the imaging modality used for procedural guidance. We, therefore, used data from a large multicenter data repository to compare the outcomes of TAVI guided exclusively by Angio and ATEE. All consecutive patients with severe aortic stenosis who underwent TAVI with the CoreValve Revalving System (CRS) in 9 Italian centers from September 2007 to March 2014, dichotomized according to the imaging support used to guide the procedure (ATEE and Angio), were included. Thirty-day and 12-month clinical outcomes were evaluated. Propensity matching analysis was performed to adjust for baseline differences. A total of 625 patients were included (256 and 369 patients were included in the ATEE and Angio groups, respectively). Patients from the ATEE more frequently underwent TAVI under general anesthesia compared with Angio group (37.9% vs 22.8%, respectively, p <0.001). Importantly, ∼80% of the patients experienced mild or even less aortic regurgitation as assessed by angiography after the procedure, without between-group differences. Postdilation and valve-in-valve rates were equivalent (24.7% vs 25%, p = 0.934 and 5.5% vs 3.4%, respectively, p = 0.217). No differences were revealed in the rates of death, cardiovascular death, and stroke or transient ischemic attack at 12-month follow-up. These results were sustained after propensity matching analysis. In conclusion, as long as a comprehensive procedural planning is performed, TAVI with CRS may be performed exclusively under angiographic guidance without the need for associated TEE.

Management and Long-Term Prognosis of Spontaneous Coronary Artery Dissection.

The optimal management and short- and long-term prognoses of spontaneous coronary artery dissection (SCAD) remain not well defined. The aim of this observational multicenter study was to assess long-term clinical outcomes in patients with SCAD. In-hospital and long-term outcomes were assessed in 134 patients with documented SCAD, as well as the clinical impact and predictors of a conservative rather than a revascularization strategy of treatment. The mean age was 52 ± 11, years and 81% of patients were female. SCAD presented as an acute coronary syndromes in 93% of patients. A conservative strategy was performed in 58% of patients and revascularization in 42%. On multivariate analysis, distal versus proximal or mid location of dissection (odds ratio 9.27) and basal Thrombolysis In Myocardial Infarction (TIMI) flow grade 2 or 3 versus 0 or 1 (odds ratio 0.20) were independent predictors of conservative versus revascularization strategy. A conservative strategy was associated with better in-hospital outcomes compared with revascularization (rates of major adverse cardiac events 3.8% and 16.1%, respectively, p = 0.028); however, no significant differences were observed in the long-term outcomes. In conclusion, in this large observational study of patients with SCAD, angiographic features significantly influenced the treatment strategy, providing an excellent short- and long-term prognosis.

Impact of balloon post-dilation on clinical outcomes after transcatheter aortic valve replacement with the self-expanding CoreValve prosthesis.

OBJECTIVES: The aim of this study was to assess the incidence and clinical impact of balloon post-dilation (BPD) after transcatheter aortic valve replacement (TAVR) with the CoreValve prosthesis (Medtronic Inc., Minneapolis, Minnesota). BACKGROUND: BPD is a widely adopted strategy to reduce the degree of paraprosthetic regurgitation in case of transcatheter heart valve underexpansion. However, controversies still remain regarding its real effectiveness and safety. METHODS: The ClinicalService (a nation-based data repository and medical care project) dataset was analyzed. All patients were dichotomized according to the need for BPD during the index procedure. RESULTS: Among 1,376 patients, BPD of the transcatheter heart valve was performed in 272 (19.8%). In 37% of cases, it was unsuccessful at reducing the paravalvular regurgitation to mild or less. No case of valve embolization, new intravalvular regurgitation, coronary occlusion, and aortic root injury occurred during BPD. There were no statistically significant differences between the 2 groups in the incidence of in-hospital all-cause and cardiovascular mortality, neurological events, myocardial infarction, bleeding, conversion to open-chest surgery, and the need for a permanent pacemaker. The need for BPD did not emerge as an independent risk factor for all-cause (adjusted hazard ratio [HR]: 1.33, 95% confidence interval [CI]: 0.81 to 2.19, p = 0.264) and cardiovascular (adjusted HR: 1.48, 95% CI: 0.74 to 2.97, p = 0.265) mortality at 1 year after the procedure. In addition, BPD did not predispose to higher odds of neurological events during 12 months after TAVR (HR: 0.92, 95% CI: 0.45 to 1.88, p = 0.815). CONCLUSIONS: This large study showed that BPD after TAVR was safe and not associated with increased rates of cerebrovascular events, mortality, myocardial infarction, and aortic root injury.

Direct transcatheter aortic valve implantation with self-expandable bioprosthesis: feasibility and safety.

BACKGROUND: Balloon valvuloplasty has been considered a mandatory step of the transcatheter aortic valve implantation (TAVI), although it is not without risk. The aim of this work was to evaluate the feasibility and safety of TAVI performed without pre-dilation (direct TAVI) of the stenosed aortic valve. MATERIAL AND METHODS: Between June 2012 and June 2013, 55 consecutive TAVI performed without pre-dilation at our institution using the self-expandable CoreValve prosthesis (Medtronic, Minneapolis, MN) were analyzed and compared with 45 pre-dilated TAVI performed the previous year. Inclusion criteria were a symptomatic and severe aortic stenosis. Exclusion criteria were defined as presence of pure aortic regurgitation, degenerated surgical bioprosthesis or bicuspid aortic valve and prior procedure of balloon aortic valvuloplasty performed as a bridge to TAVI. RESULTS: High-burden calcification in the device landing zone, assessed by CT scan, was found in most of the patients. The valve size implanted was similar in both groups. Device success was higher in direct TAVI (85%vs.64%,p=0.014), mostly driven by a significant lower incidence of paravalvular leak (PVL≥2;9%vs.33%,p=0.02). Safety combined end point at 30 days was similar in both groups. CONCLUSION: Compared to TAVI with pre-dilation, direct TAVI is feasible regardless of the presence of bulky calcified aortic valve and the valve size implanted. Device success was higher in direct TAVI, mostly driven by a lower incidence of paravalvular leak. Safety at 30 days was similar in two groups.

Transcatheter treatment of chronic mitral regurgitation with the MitraClip system: an Italian consensus statement.

New percutaneous technologies are rapidly emerging for the treatment of structural heart disease including mitral valve disease. Preliminary data suggest a potential clinical benefit of percutaneous treatment of mitral regurgitation by the MitraClip procedure in selected patients. Until final data are available from randomized, controlled, multicenter clinical trials, there is an urgent need for a consensus among all the operators involved in the treatment of patients with mitral regurgitation, including clinical cardiologists, heart failure specialists, surgeons, interventional cardiologists, and imaging experts. In the absence of evidence-based guidelines, the heart-team approach is the most reliable method of making proper decisions. This study is the result of multidisciplinary consensus activity, and has the aim of helping physicians in the difficult task of making decisions for the treatment of patients with mitral regurgitation. It is the result of a joint effort of the major Italian Cardiology and Cardiac Surgery Societies, working together to find a proper balance between the points of view of the clinical cardiologist, the interventional cardiologist, and the cardiac surgeon.

The valve-in-valve technique for treatment of aortic bioprosthesis malposition an analysis of incidence and 1-year clinical outcomes from the italian CoreValve registry.

OBJECTIVES: We appraised the incidence and clinical outcomes of patients who were treated with the valve-in-valve (ViV) technique for hemodynamically destabilizing paraprosthetic leak (PPL). BACKGROUND: Device malpositioning causing severe PPL after transcatheter aortic valve implantation is not an uncommon finding. It occurs after release of the prosthesis, leading to hemodynamic compromise. It can be managed successfully in selected cases with implantation of a second device inside the malpositioned primary prosthesis (ViV technique). METHODS: Consecutive patients (n = 663) who underwent transcatheter aortic valve implantation with the 18-F CoreValve ReValving System (Medtronic, Inc., Minneapolis, Minnesota) at 14 centers across Italy were included in this prospective web-based registry. We identified patients treated with the ViV technique for severe PPL and analyzed their clinical and echocardiographic outcomes. Primary end points were major adverse cerebrovascular and cardiac events and prosthesis performance at the 30-day and midterm follow-up. RESULTS: Overall procedural success was obtained in 650 patients (98.0%). The ViV technique was used in 24 (3.6%) of 663 patients. The 30-day major adverse cerebrovascular and cardiac event rates were 7.0% and 0% in patients undergoing the standard procedure and ViV technique, respectively (p = 0.185); the mortality rates were 5.6% versus 0% in patients undergoing the standard procedure and ViV technique, respectively (p = 0.238). There was an improvement in the mean transaortic gradient in all patients without significant difference between the 2 groups (from 52.1 ± 17.1 mm Hg and 45.4 ± 14.8 mm Hg [p = 0.060] to 10.1 ± 4.2 mm Hg and 10.5 ± 5.2 mm Hg, respectively [p = 0.838]). At 12 months, the major adverse cerebrovascular and cardiac event rates in the standard procedure and ViV technique groups were 4.5% and 14.1%, respectively (p = 0.158), and the mortality rates were 4.5% versus 13.7%, respectively (p = 0.230). CONCLUSIONS: This large, multicenter registry provides important information about the feasibility, safety, and efficacy of the ViV technique with the third-generation CoreValve ReValving System. The clinical and echocardiographic end points compare favorably with those of patients undergoing the standard procedure. The ViV technique offers a viable therapeutic option in patients with acute significant PPL without recourse to emergent surgery.

Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis.

BACKGROUND: There is a lack of information on the incidence and predictors of early mortality at 30 days and late mortality between 30 days and 1 year after transcatheter aortic valve implantation (TAVI) with the self-expanding CoreValve Revalving prosthesis. METHODS AND RESULTS: A total of 663 consecutive patients (mean age 81.0 ± 7.3 years) underwent TAVI with the third generation 18-Fr CoreValve device in 14 centers. Procedural success and intraprocedural mortality were 98% and 0.9%, respectively. The cumulative incidences of mortality were 5.4% at 30 days, 12.2% at 6 months, and 15.0% at 1 year. The incidence density of mortality was 12.3 per 100 person-year of observation. Clinical and hemodynamic benefits observed acutely after TAVI were sustained at 1 year. Paravalvular leakages were trace to mild in the majority of cases. Conversion to open heart surgery (odds ratio [OR] 38.68), cardiac tamponade (OR 10.97), major access site complications (OR 8.47), left ventricular ejection fraction <40% (OR 3.51), prior balloon valvuloplasty (OR 2.87), and diabetes mellitus (OR 2.66) were independent predictors of mortality at 30 days, whereas prior stroke (hazard ratio [HR] 5.47), postprocedural paravalvular leak ≥ 2+ (HR 3.79), prior acute pulmonary edema (HR 2.70), and chronic kidney disease (HR 2.53) were independent predictors of mortality between 30 days and 1 year. CONCLUSIONS: Benefit of TAVI with the CoreValve Revalving System is maintained over time up to 1 year, with acceptable mortality rates at various time points. Although procedural complications are strongly associated with early mortality at 30 days, comorbidities and postprocedural paravalvular aortic regurgitation ≥ 2+ mainly impact late outcomes between 30 days and 1 year.

Early experience with a new approach for percutaneous intervention of totally occluded saphenous vein graft: is the flow the best thrombolytic?

AIMS: Percutaneous coronary intervention (PCI) in the total occlusion of aged saphenous vein grafts (SVGO) is difficult because of inadequate dilatation and distal embolisation. The aim of this study is to report the early experience and clinical outcome of SVGO PCI with a multistaged procedure. METHODS AND RESULTS: Between January 2003-2006, we treated 20 consecutive patients (pts) admitted with the diagnosis of non-ST segment elevation acute coronary syndromes with culprit lesion located in SVGO. All of them underwent a three stage procedure. Stage 1: recanalisation of graft with undersized balloon; Stage 2: anticoagulation therapy; Stage 3: treatment according to the angiographic result. We obtained vessel recanalisation with TIMI flow 1-2 in 14 pts (70%) by undersized balloon (mean diameter of 1,85±0,43 mm). The mean anticoagulation time was 11±7 days (range 1-20 days). At the Stage 3 all 14 SVG (100%) were patent. A focal lesion was present in 12 pts (86%) treated by stent implantation. In the other two pts (14%) the SVG had no residual lesion. The in-hospital major adverse cardiac event rate was 10%. No death, in-hospital late closure or major bleeding complication occurred. At 2-year follow-up one target vessel revascularisation and one in stent restenosis occurred. CONCLUSIONS: The treatment of SVGO with staged procedure may be used to decrease thrombus burden prior to definitive "short" stent placement and improve the acute and long-term results.

Emergency surgery after saphenous vein graft perforation complicated by catheter balloon entrapment and hemorrhagic shock.

Emergency surgery for acute vein graft perforation and balloon entrapment during percutaneous angioplasty is reported here. Prompt extracorporeal circulation through peripheral cannulation enabled the control of systemic perfusion despite cardiac arrest. Vein graft repair was achieved by an autologous pericardial patch. Appropriate and tailored mechanical circulatory support allowed successful extracorporeal circulation withdrawal, limited intraoperative cardiac damage, and postoperative controlled recovery of ventricular function with ultimate favorable outcome.

Coronary-to-bronchial anastomosis: an unusual cause of hemoptysis.

Coronary-to-bronchial anastomosis (CBA) is a rare anomaly. This vascular abnormality may be subclinical or be responsible for several pathophysiological events and symptoms involving the respiratory and/or the coronary system. We report the case of a patient with hemoptysis caused by this anomalous coronary-to-bronchial communication, who was concomitantly affected by aortic stenosis and coronary artery disease requiring surgical treatment. A coronary angiogram clearly demonstrated the abnormal vascular connection between the proximal right coronary artery and the bronchial arteries of the left inferior right lobe. The coronary branch was intra-operatively identified and ligated, in association with aortic valve replacement and coronary artery bypass, with an uneventful postoperative course and resolution of the respiratory symptoms. This case presents an unusual cause of hemoptysis due to CBA in patients with other cardiac comorbidities, which required surgical treatment, allowing direct ligation of the CBA. A review of the clinical and therapeutic characteristics of such a peculiar vascular abnormality is also provided.

Coronary rotational atherectomy in current practice: acute and mid-term results in high- and low-volume centers.

We conducted a prospective observational study to evaluate the indications, technique, in-hospital and 9-month results of consecutive patients treated with rotational atherectomy (RA) in 12 centers during 1 year, as well as their relationship with volume of RA activity. The study included 345 lesions in 289 patients treated (4.4% +/- 2.6% of procedures at the participating centers). The lesions were mostly calcified (63%) and type B2 or C (74%). Procedural success was obtained in 94% of patients, with a major adverse cardiac event (MACE) rate of 4.5%. At 9 months, MACE occurred in 17.3%. Multivariate analysis identified multivessel disease and slow flow as negative predictors of procedural success, whereas balloon pressure

Immediate results and one-year clinical outcome after percutaneous coronary interventions in chronic total occlusions: data from a multicenter, prospective, observational study (TOAST-GISE).

OBJECTIVES: We sought to investigate the success rate and the acute and 12-month clinical outcome of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) in the contemporary era. BACKGROUND: The technique of PCI involving CTO has improved over time. However, limited data on acute and follow-up results in patients treated with PCI on CTO in recent years are available. METHODS: Four hundred nineteen consecutive patients scheduled for PCI of CTO of > or =30 days of duration were enrolled in 29 centers; 390 CTOs were confirmed in 376 patients in an independent core laboratory. The end points were technical and procedural success, in-hospital and 12-month major adverse cardiac events (MACE) occurrence, and 12-month symptomatic status. RESULTS: Technical and procedural success was obtained in 77.2% and 73.3% of lesions, respectively. In-hospital major adverse cardiac events occurred in 5.1% of patients. Multivariate analysis identified CTO length >15 mm or not measurable, moderate to severe calcifications, duration > or =180 days, and multivessel disease as significant predictors of PCI failure. At 12 months, patients with a successful procedure experienced a lower incidence of cardiac deaths or myocardial infarction (1.05% vs. 7.23%, p = 0.005), a reduced need for coronary artery bypass surgery (2.45% vs. 15.7%, p < 0.0001), and were more frequently free of angina (88.7% vs. 75.0%, p = 0.008) compared with patients who had an unsuccessful procedure. CONCLUSIONS: Successful PCI was achieved in a high percentage of CTOs with a low incidence of complications. At one-year follow-up, patients with successful PCI of a CTO had a significantly better clinical outcome than those whose PCI was unsuccessful.