R. Michael Wyman

Current complications of diagnostic and therapeutic cardiac catheterization

Data from 2,883 cardiac catheterizations performed during an 18 month period (from July 1986 through December 1987) were analyzed to assess the current complication profile of diagnostic and therapeutic procedures. Procedures performed during the study period included 1,609 diagnostic catheterizations, 933 percutaneous transluminal coronary angioplasties and 199 percutaneous balloon valvuloplasties. Overall, the mortality rate was 0.28% but ranged from 0.12% for diagnostic catheterizations to 0.3% for coronary angioplasty and 1.5% for balloon valvuloplasty. Emergency cardiac surgery was required in 12 angioplasty patients (1.2%). Cardiac perforation occurred in seven patients (0.2%), of whom six were undergoing valvuloplasty, and five (2.5% of valvuloplasty attempts) required emergency surgery for correction. Local vascular complications requiring operative repair occurred in 1.9% of patients overall, ranging from 1.6% for diagnostic catheterization to 1.5% for angioplasty and 7.5% for valvuloplasty. Although the complication rates for diagnostic catheterization compare favorably with those of previous multicenter registries, current overall complication rates are significantly higher because of the performance of therapeutic procedures with greater intrinsic risk and the inclusion of increasingly aged and acutely ill or unstable patients.

Balloon aortic valvuloplasty in 170 consecutive patients

Between October 1, 1985, and April 1, 1988, we performed balloon aortic valvuloplasty in 170 patients (mean age [+/- SD], 77 +/- 5 years) who had symptomatic aortic stenosis. The procedure was completed successfully in 168 patients and resulted in significant increases in the mean (+/- SD) aortic-valve area (from 0.6 +/- 0.2 to 0.9 +/- 0.3 cm2) and cardiac output (from 4.6 +/- 3.4 to 4.8 +/- 1.4 liters per minute) and decreases in the peak aortic-valve pressure gradient (from 71 +/- 20 to 36 +/- 14 mm Hg) (P less than 0.01 for all three comparisons). There were six in-hospital deaths, and five patients required early aortic-valve replacement. Follow-up data were available for all patients, for a period averaging 9.1 months. In addition to the 6 patients who died in the hospital, 25 patients died an average of 6.4 +/- 5.3 months after discharge. Symptoms recurred in 44 patients; they were managed by repeat valvuloplasty in 16 patients, by aortic-valve replacement in 17, and by medical therapy in 11. At the most recent follow-up examination, the symptoms of 103 patients had improved after valvuloplasty; this number includes 15 patients with restenosis who successfully underwent redilation. Life-table analysis indicates that the probability of survival 12 months after the procedure was 74 percent. We conclude that balloon aortic valvuloplasty is an effective palliative therapy for some elderly patients with symptomatic aortic stenosis. Symptoms improve in the majority of patients; although restenosis is common, it can be managed in some patients by repeat balloon dilation.

Use of a novel crossing and re-entry system in coronary chronic total occlusions that have failed standard crossing techniques: Results of the FAST-CTOs (facilitated antegrade steering technique in chronic total occlusions) trial

OBJECTIVES This study sought to examine the efficacy and safety of 3 novel devices to recanalize coronary chronic total occlusions (CTOs). BACKGROUND Successful percutaneous coronary intervention (PCI) of CTOs improves clinical outcome in appropriately selected patients. CTO PCI success, however, remains suboptimal. METHODS A new crossing catheter and re-entry system was evaluated in a prospective, multicenter, single-arm trial of CTO lesions refractory to standard PCI techniques. The primary efficacy endpoint was the frequency of true lumen guidewire placement distal to the CTO (technical success). RESULTS Enrollment included 147 patients with 150 CTOs. The mean lesion length was 41 ± 17 mm. A crossing catheter crossed 56 lesions into the distal true lumen, and a re-entry catheter facilitated tapered-wire cannulation of the distal lumen in 59 CTOs initially crossed subintimally (77% technical success). Success in the first 75 CTOs was 67%, rising to 87% in the last 75 CTOs. Mean fluoroscopy and procedure times were 45 ± 16 min and 90 ± 12 min, respectively, each significantly shorter than in historical controls (p < 0.0001 for both). Coronary perforation occurred in 14 cases (9.3%), requiring treatment in 3 cases (prolonged balloon inflation, with additional coil embolization in 1 case). No tamponade or hemodynamic instability occurred. Six patients had periprocedural non-ST-segment elevation myocardial infarction. No emergency surgery, ST-segment elevation myocardial infarction, or cardiac reintervention occurred. Two deaths occurred within 30 days, neither as a direct result of the procedure. The 30-day major adverse cardiac event rate was 4.8%. CONCLUSIONS In CTOs failing standard techniques, use of a new crossing and re-entry system results in a high success rate without increasing complications.

Application and outcomes of a hybrid approach to chronic total occlusion percutaneous coronary intervention in a contemporary multicenter US registry

BACKGROUND A hybrid approach to chronic total occlusion (CTO) percutaneous coronary intervention (PCI) prioritizing and combining all available crossing techniques was developed to optimize procedural efficacy, efficiency, and safety, but there is limited published data on its outcomes. METHODS We examined the procedural techniques and outcomes of 1036 consecutive CTO PCIs performed using a hybrid approach between 2012 and 2015 at 11 US centers. RESULTS Mean age was 65 ± 10 years and 86% of the patients were men, with a high prevalence of diabetes mellitus (43%) and prior coronary artery bypass graft surgery (34%). Most target CTOs were located in the right coronary artery (59%), followed by the left anterior descending artery (23%) and the circumflex (19%). Dual injection was used in 71%. Technical success was achieved in 91% and a major procedural complication occurred in 1.7% of cases. The final successful crossing technique was antegrade wire escalation in 46%, antegrade dissection/re-entry in 26%, and retrograde in 28%. The initial crossing strategy was successful in 58% of the lesions, whereas 39% required an additional approach. Overall, antegrade wire escalation was used in 71%, antegrade dissection/re-entry in 36%, and the retrograde approach in 42% of procedures. Median contrast volume, fluoroscopy time, and air kerma radiation dose were 260 (200-360) ml, 44 (27-72) min, and 3.4 (2.0-5.4) Gray, respectively. CONCLUSION Application of a hybrid approach to CTO crossing resulted in high success and low complication rates across a varied group of operators and hospital practice structures, supporting its expanding use in CTO PCI.

Outcomes With the Use of the Retrograde Approach for Coronary Chronic Total Occlusion Interventions in a Contemporary Multicenter US Registry

Background—We sought to examine the efficacy and safety of chronic total occlusion percutaneous coronary intervention using the retrograde approach. Methods and Results—We compared the outcomes of the retrograde versus antegrade-only approach to chronic total occlusion percutaneous coronary intervention among 1301 procedures performed at 11 experienced US centers between 2012 and 2015. The mean age was 65.5±10 years, and 84% of the patients were men with a high prevalence of diabetes mellitus (45%) and previous coronary artery bypass graft surgery (34%). Overall technical and procedural success rates were 90% and 89%, respectively, and in-hospital major adverse cardiovascular events occurred in 31 patients (2.4%). The retrograde approach was used in 539 cases (41%), either as the initial strategy (46%) or after a failed antegrade attempt (54%). When compared with antegrade-only cases, retrograde cases were significantly more complex, both clinically (previous coronary artery bypass graft surgery prevalence, 48% versus 24%; P<0.001) and angiographically (mean Japan-chronic total occlusion score, 3.1±1.0 versus 2.1±1.2; P<0.001) and had lower technical success (85% versus 94%; P<0.001) and higher major adverse cardiovascular events (4.3% versus 1.1%; P<0.001) rates. On multivariable analysis, the presence of suitable collaterals, no smoking, no previous coronary artery bypass graft surgery, and left anterior descending artery target vessel were independently associated with technical success using the retrograde approach. Conclusions—The retrograde approach is commonly used in contemporary chronic total occlusion percutaneous coronary intervention, especially among more challenging lesions and patients. Although associated with lower success and higher major adverse cardiovascular event rates in comparison to antegrade-only crossing, retrograde percutaneous coronary intervention remains critical for achieving overall high success rates.

Clinical Utility of the Japan–Chronic Total Occlusion Score in Coronary Chronic Total Occlusion Interventions Results from a Multicenter Registry

Background—The performance of the Japan–chronic total occlusion (J-CTO) score in predicting success and efficiency of CTO percutaneous coronary intervention has received limited study. Methods and Results—We examined the records of 650 consecutive patients who underwent CTO percutaneous coronary intervention between 2011 and 2014 at 6 experienced centers in the United States. Six hundred and fifty-seven lesions were classified as easy (J-CTO=0), intermediate (J-CTO=1), difficult (J-CTO=2), and very difficult (J-CTO≥3). The impact of the J-CTO score on technical success and procedure time was evaluated with univariable logistic and linear regression, respectively. The performance of the logistic regression model was assessed with the Hosmer–Lemeshow statistic and receiver operator characteristic curves. Antegrade wiring techniques were used more frequently in easy lesions (97%) than very difficult lesions (58%), whereas the retrograde approach became more frequent with increased lesion difficulty (41% for very difficult lesions versus 13% for easy lesions). The logistic regression model for technical success demonstrated satisfactory calibration and discrimination (P for Hosmer–Lemeshow =0.743 and area under curve =0.705). The J-CTO score was associated with a 2-fold increase in the odds of technical failure (odds ratio 2.04, 95% confidence interval 1.52–2.80, P<0.001). Procedure time increased by ≈20 minutes for every 1-point increase of the J-CTO score (regression coefficient 22.33, 95% confidence interval 17.45–27.22, P<0.001). Conclusions—J-CTO score was strongly associated with final success and efficiency in this study, supporting its expanded use in CTO interventions. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT02061436.

Procedural failure of chronic total occlusion percutaneous coronary intervention: Insights from a multicenter US registry

The hybrid approach to chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has significantly increased procedural success rates, yet some cases still fail. We sought to evaluate the causes of failure in a contemporary CTO PCI registry.

Initial experience with a dedicated coronary re‐entry device for revascularization of chronic total occlusions

Objective: The aim of this registry was to evaluate a new device designed to facilitate antegrade guidewire re‐entry into the true lumen of a chronic total coronary occlusion (CTO) from the adjacent subintimal space. Background: Successful recanalization of CTOs results in clinical improvement in appropriately selected patients. CTO intervention is time‐ and resource‐consuming, and a simplified approach enabling antegrade guidewire re‐entry into the distal true lumen might improve success. Methods: Patients with CTO and ischemia were entered into a prospective registry regardless of lesion characteristics. If wire manipulation resulted in subintimal wire entrapment, a new re‐entry tool (a 2.5‐mm flat subintimal balloon with two exit ports offset by 180°) was used as a platform to attempt guidewire penetration into the distal true lumen. The primary endpoint assessed was successful device‐guided re‐entry. Standard techniques were then utilized to open the CTO. Results: In 40 consecutive CTO lesions attempted, 19 resulted in subintimal wire entrapment (mean occlusion length 44 mm). Sixteen of these 19 were successfully crossed with an antegrade guidewire into the distal true lumen using the new device (84%). One patient with unsuccessful re‐entry was subsequently recanalized with a retrograde technique. All crossed lesions were stented (17/17), resulting in TIMI 3 flow without major complications. Two cases were unsuccessful. One patient had a grade I coronary perforation requiring no treatment. Conclusions: A new device to recanalize CTOs complicated by subintimal wire entrapment can be used successfully by experienced operators. Further study of this coronary re‐entry device is ongoing.

Use of balloon flotation pacing catheters for prophylactic temporary pacing during diagnostic and therapeutic catheterization procedures

The use of prophylactic temporary pacemakers during diagnostic catheterization, coronary angioplasty and percutaneous balloon valvuloplasty was investigated retrospectively over an 18-month period. Balloon flotation temporary pacemaker leads were placed in 193 (12%) of 1,609 patients undergoing diagnostic catheterization, 641 (65%) of 993 patients undergoing coronary angioplasty and 199 (100%) of 199 patients undergoing aortic or mitral valvuloplasty. There were no perforations or significant arrhythmic complications related to pacemaker placement in these 1,033 cases, and pacing was initiated promptly when required by withdrawal of the catheter tip into the right ventricle. Significant bradycardia or new conduction defects developed in 17 patients (1%) during diagnostic catheterization, 10 patients (1%) during angioplasty and 20 patients (10%) during valvuloplasty, but were severe enough to require initiation of temporary pacing in only 1 (0.06%), 4 (0.4%) and 5 (2.5%) patients, respectively. No patient undergoing diagnostic catheterization or angioplasty (but 5 patients undergoing valvuloplasty) required immediate pacing support to treat a life-threatening bradycardia. The total cost of prophylactic pacemakers was

The Outcomes, Patient Health Status, and Efficiency IN Chronic Total Occlusion Hybrid Procedures registry: rationale and design

103,300, with a cost per actual use of